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- library
- Mycamine® (micafungin) – First-time generic
- Darzalex® (daratumumab), Kyprolis® (carfilzomib) – Expanded indication
- Invokana® (canagliflozin), Invokamet® (canagliflozin/metformin) and Invokamet XR (canagliflozin/metformin extended-release) – Label updates
- Mirena® (levonorgestrel-releasing intrauterine system) – Expanded indication
- Xeomin® (incobotulinumtoxinA) – Expanded indication
- Xyntha ®, Xyntha Solofuse® (antihemophilic factor [recombinant]) – New indication
- Cystadrops® (cysteamine) – New drug approval
- Kesimpta® (ofatumumab) – New drug approval
- Tecfidera® (dimethyl fumarate) – First-time generic approval
- RLC Labs – Recall of Nature-Throid® (thyroid) and WP Thyroid® (thyroid)
- Sogroya® (somapacitan-beco) – New drug approval
- Winlevi® (clascoterone) – New drug approval
- Moviprep® (polyethylene glycol 3350/sodium sulfate/sodium chloride/potassium chloride/ascorbic acid/sodium ascorbate) – First-time generic
- Rifampin and Priftin® (rifapentine) – Safety update
- Camcevi® (leuprolide) – New drug approval
- Triumeq PD (abacavir/dolutegravir/lamivudine) – New formulation approval
- Kepivance® (palifermin) – Label update
- Suprenza™ (phentermine) – Drug Discontinuation
- Ziana™ (clindamycin phosphate/tretinoin) – First-Time Generic
- RxOutlook - 4th Quarter 2016
- Xolair® (omalizumab) – Expanded Indication
- RxOutlook - 3rd Quarter 2016
- RxOutlook - 2nd Quarter 2016
- Differin™ (adapalene) – New Over-The-Counter Drug Approval
- Guideline Update on Statin Use
- Vemlidy® (tenofovir alafenamide) – New Drug Approval
- Delestrogen® (estradiol valerate) – Drug Shortage
- Opdivo™ (nivolumab) – New Indication
- Vistaril® (hydroxyzine), Xyzal® (levocetirizine) – Safety Communication
- Bonjesta™ doxylamine/pyridoxine) – New Drug Approval
- Selzentry® (maraviroc) – Expanded Indication, New Formulation
- Enbrel® (etanercept) – Expanded Indication
- Imodium® (loperamide) – New Boxed Warning
- Seroquel XR® (quetiapine) – First-Time Generic
- Auryxia™ (ferric citrate) – Drug Shortage
- Benicar® (olmesartan), Benicar HCT® (olmesartan/hydrochlorothiazide) – First-Time Generics
- Azor® (amlodipine/olmesartan), Tribenzor™ (olmesartan/amlodipine/hydrochlorothiazide) – First-Time Generics
- Testosterone Products – New Warning
- Proton Pump Inhibitors – New Warning
- Keytruda® (pembrolizumab) – New and Updated Indications
- Zinplava™ (bezlotoxumab) – New Drug Approval
- Lartruvo™ (olaratumab) – New Orphan Drug Approval
- Zemplar® (paricalcitol) – Expanded Indications
- Tarceva® (erlotinib) – Updated Indication
- Treanda® (bendamustine) – New Warning
- Cervarix® [human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] – Product Discontinuation
- Tecentriq® (atezolizumab) – New Indication
- Sumavel® DosePro® (sumatriptan) – Product Discontinuation
- Vagifem® (estradiol) – First-Time Generic
- Dutoprol® (metoprolol succinate extended-release/hydrochlorothiazide) – First-Time Generic
- Rajani™ (drospirenone/ethinyl estradiol/levomefolate and levomefolate) – First-Time Generic
- Amitiza® (lubiprostone) – New Warning
- Pertzye® (pancrelipase) – Expanded Indication and New Formulation
- Flublok® Quadrivalent (influenza vaccine) – New Formulation Approval
- Carnexiv™ (carbamazepine) – New Orphan Drug Approval
- Opdivo® (nivolumab) – New Warnings
- Direct-Acting Antivirals – Safety Communication
- Xopenex HFA® (levalbuterol tartrate) – First-Time Generic
- Tyzeka® (telbivudine) – Product Discontinuation
- Epzicom® (abacavir/lamivudine) – First-time generic
- Orkambi® (lumacaftor/ivacaftor) – Expanded indication and new dosage form
- Stelara™ (ustekinumab) – New Indication
- Ilaris® (canakinumab) – New Indications
- Amjevita™ (adalimumab-atto) – New Biosimilar Approval
- Zydelig® (idelalisib) – Label Updates
- Cordran® (flurandrenolide) Lotion – First-time Generic
- Invokamet® XR (canagliflozin/metformin extended-release) – New Formulation Approval
- Kyleena™ (levonorgestrel-releasing intrauterine system) – New Drug Approval
- Exondys 51™ (eteplirsen) – New Orphan Drug Approval
- Repatha® (evolocumab) – New Formulation Approval
- Dexlansoprazole [Dexilant™, Dexilant™ SoluTab] – Expanded Indication
- Xiidra™ (lifitegrast) – New Drug Approval
- Prevnar™ 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) – Expanded Indication
- Biosimilar Humira® (adalimumab) and Enbrel® (etanercept) – FDA Advisory Committee Recommendations
- PharmaTech/Rugby – Recall of Diocto Liquid
- Nilandron® (nilutamide) – First-Time Generic
- Berinert® (C1 esterase inhibitor [human]) – Expanded Indication
- Prezista® (darunavir) – Expanded Indication
- Belviq XR® (lorcaserin) – New Formulation Approval
- Photrexa® Viscous (riboflavin 5’-phosphate in 20% dextran) and Photrexa® (riboflavin 5’-phosphate) – New Indication
- Synjardy® (empagliflozin/metformin) – Expanded Indication
- Relistor® (methylnaltrexone bromide) – New Formulation Approval
- Namzaric® (memantine/donepezil) – Expanded Indication
- Viekira XR™ – New Formulation Approval
- Fluoroquinolones – Safety Communication
- Adlyxin™ (lixisenatide) – New Drug Approval
- Teva Pharmaceuticals – Recall of Amikacin Injection
- Qbrelis™ (lisinopril) – New Drug Approval
- Asacol® HD (mesalamine) – First-Time Generic
- Dysport® (abobotulinumtoxinA) – New Indication
- Tamiflu® (oseltamivir) – First-Time Generic
- Kyprolis® (carfilzomib) – New Warning
- Movantik® (naloxegol) – New Warning
- Keytruda® (pembrolizumab) – New Indication
- Cubicin® (daptomycin) – First-Time Generic
- Yosprala™ (aspirin/omeprazole) – New Drug Approval
- Cuvitru™ (immune globulin subcutaneous [human], 20% solution) – New Drug Approval
- Virtus Pharmaceuticals – Recall of Hyoscyamine Sulfate
- Jevtana® (cabazitaxel) – New Warning
- PharmaTech – Recall of Liquid Products
- Cortef®, Solu-Cortef® and Solu-Medrol® – New Warnings
- Novo Nordisk – Recall of GlucaGen® HypoKit®
- Sustol® (granisetron) – New Drug Approval
- Family Care, Major, and Rugby – Recall of Eye Solutions
- Blincyto® (blinatumomab) – Expanded Dosing and New Warnings
- Sagent Pharmaceuticals – Recall of Oxacillin Injection
- Trokendi XR® (topiramate) – Expanded Indication
- Troxyca® ER (oxycodone/naltrexone) – New Drug Approval
- Lamisil® (terbinafine) – New Contraindication
- EpiPen® (epinephrine) – First-Time Generic
- Nitrostat® (nitroglycerin) – First-Time Generic
- Sustiva® (efavirenz) – New Warning
- Arzerra® (ofatumumab) – Expanded Indication
- Opioids and Benzodiazepines – Safety Communication
- Valcyte® (valganciclovir) oral solution – First-Time Generic
- Erelzi™ (etanercept-szzs) – New Biosimilar Approval
- FluLaval® Quadrivalent (influenza vaccine) – Expanded Indication
- Naftin® (naftifine) 2% cream – Expanded Indication
- Intrarosa™ (prasterone) – New Drug Approval
- RxOutlook - 1st Quarter 2016
- Lindane – Product Discontinuation
- Vitekta® (elvitegravir) – Product Discontinuation
- Soliqua™ 100/33 (insulin glargine/lixisenatide) – New Drug Approval
- Xultophy® 100/3.6 (insulin degludec/liraglutide) – New Drug Approval
- Ocufen® (flurbiprofen) – Product Discontinuation
- CellCept® IV (mycophenolate mofetil) – First-Time Generic
- Sarafem® (fluoxetine) – First-Time Generic
- Cefzil® (cefprozil), Ceftin® (cefuroxime) – Indication Removal
- Veltassa® (patiromer) – Removal of Boxed Warning
- Vibativ® (telavancin) – Product Discontinuation
- Prestalia® (perindopril/amlodipine) – New and Updated Warnings
- Jardiance® (empagliflozin) – New Indication
- Kaletra® (lopinavir/ritonavir) – Updated Contraindications/Drug Interactions
- Renvela® (sevelamer) – Expanded Indication
- Supernus – Recall of Trokendi XR® (topiramate)
- Penicillin G Procaine – Drug Shortage
- Avastin® (bevacizumab) – Expanded Indication
- Isopto® Atropine (atropine sulfate) – New Drug Approval
- Latisse® (bimatoprost) – First-Time Generic
- Synjardy® XR (empagliflozin/metformin extended-release) – New Formulation Approval
- Zetia® (ezetimibe) – First-Time Generic
- Eucrisa™ (crisaborole) – New Drug Approval
- EpiPen® (epinephrine) – Authorized Generic Launch
- Alogliptin-containing products (Nesina®, Oseni®, Kazano®) – New Warning
- General Anesthetic and Sedation Drugs – Safety Update
- Fresenius Kabi – Recall of Midazolam Injection
- Rubraca™ (rucaparib) – New Orphan Drug Approval
- Doribax® (doripenem) – First-Time Generic
- Chantix® (varenicline) and Zyban® (bupropion) – Safety Update
- Tresiba® (insulin degludec) – Expanded Indication
- Spinraza™ (nusinersen) – New Orphan Drug Approval
- Tirosint®-Sol (levothyroxine sodium) – New Formulation Approval
- Adynovate® (antihemophilic factor [recombinant], PEGylated) – Expanded Indication
- ColPrep™ Kit (sodium sulfate/potassium sulfate/magnesium sulfate) – New Drug Approval
- Emend® (aprepitant) – First-Time Generic
- Linagliptin-containing products (Glyxambi®, Jentadueto®, Jentadueto XR®, Tradjenta® ) – New Warning
- Azilect® (rasagiline) – First-time generic
- Cordran® (flurandrenolide) – First-time generic
- Synjardy®, Synjardy XR® (empagliflozin/metformin) – Label update
- Arymo™ ER (morphine sulfate) – New Drug Approval
- Lucentis® (ranibizumab) – New Indication
- Vantrela™ ER (hydrocodone bitartrate) – New Drug Approval
- Virazole® (ribavirin) – First-Time Generic
- Bicillin® C-R (penicillin G benzathine/penicillin G procaine) products – Drug Shortage
- Enjuvia® (synthetic conjugated estrogens, B) – Product Discontinuation
- Rhofade™ (oxymetazoline) – New Drug Approval
- Trulance™ (plecanatide) – New Drug Approval
- Kaletra® (lopinavir/ritonavir) – First-Time Generic
- Xyrem® (sodium oxybate) – First-Time Generic
- Adempas® (riociguat) – New Contraindication
- Lamisil® (terbinafine) – New Warning
- Tecfidera® (dimethyl fumarate) – New Warning
- Imbruvica® (ibrutinib) – New Indication
- Saphris® (asenapine) – Expanded Indication
- Symbicort® (budesonide/formoterol fumarate dihydrate) – Expanded indication
- Latuda® (lurasidone) – Expanded indication
- American College of Physicians/American Academy of Family Physicians – Treatment of Hypertension in Adults Aged 60 Years or Older
- Tussigon® (hydrocodone/homatropine) – Updated indication, new boxed warning
- Tepadina® (thiotepa) – New Drug Approval
- Esbriet® (pirfenidone) – New Formulation Approval
- ArmonAir™ RespiClick® (fluticasone) – New drug approval
- AirDuo™ RespiClick® (fluticasone/salmeterol) – New drug approval
- Vyvanse® (lisdexamfetamine dimesylate) – New formulation approval
- Xyzal® Allergy 24HR (levocetirizine) products – Rx-to-OTC approval
- Chlorhexidine Gluconate – Safety update
- Plaquenil® (hydroxychloroquine) – New warnings
- Prolia™, Xgeva® (denosumab) – New warning
- Pylera® (bismuth subcitrate potassium/metronidazole/tetracycline) – New boxed warning
- Ofirmev® (acetaminophen) – Updated indications
- Opdivo® (nivolumab) – New indication
- Stribild® (elvitegravir/cobicistat/emtricitabine/ tenofovir) – Expanded indication and updated warnings
- Emflaza™ (deflazacort) – New orphan drug approval
- Exela Pharma Sciences – Recall of ibuprofen injection
- RxOutlook - 1st Quarter 2017
- Flonase® Sensimist™ Allergy Relief (fluticasone furoate) – Rx-to-OTC approval
- Parsabiv™ (etelcalcetide) – New drug approval
- Bendeka™ (bendamustine) – New warnings
- Advisory Committee on Immunization Practices (ACIP) – Recommended Immunization Schedule for Adults Aged 19 Years or Older, 2017
- Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report
- Siliq™ (brodalumab) – New drug approval
- Direct acting antivirals – Safety updates
- Spiriva® Respimat® (tiotropium bromide) – Expanded indication
- Endo – Recall of Edex® (alprostadil)
- Qtern® (dapagliflozin/saxagliptin) – New drug approval
- Mekinist® (trametinib) – New warning
- Revlimid® (lenalidomide) – Expanded indication
- Noctiva™ (desmopressin acetate) – New drug approval
- Odactra™ House Dust Mite – New drug approval
- Xermelo™ (telotristat ethyl) – New orphan drug approval
- Pristiq® (desvenlafaxine succinate) – First-time generic
- Unituxin® (dinutuximab) – New warnings
- Cerebyx® (fosphenytoin) – Expanded indication
- RotaTeq® (rotavirus vaccine, live, oral, pentavalent) – Expanded indication
- Technivie® (ombitasvir/paritaprevir/ritonavir) – Expanded indication
- Claris Lifesciences – Recall of injectable products
- Kisqali® (ribociclib) – New drug approval
- Paremyd® (hydroxyamphetamine/tropicamide) – Drug shortage
- Busulfex® (busulfan) – First-time generic
- Fresenius Kabi – Recall of fluphenazine decanoate injection
- Viberzi™ (eluxadoline) – Safety update
- Keytruda® (pembrolizumab) – New indication
- Repatha™ (evolocumab) – FOURIER study results
- B. Braun Medical – Recall of lactated ringer’s injection
- Bavencio® (avelumab) – New orphan drug approval
- Dupixent® (dupilumab) – New drug approval
- Ocrevus™ (ocrelizumab) – New drug approval
- Symproic® (naldemedine) – New drug approval
- Xadago® (safinamide) – New drug approval
- Zejula™ (niraparib) – New orphan drug approval
- Zyflo CR® (zileuton) – First-time generic
- Mylan – Recall of EpiPen® and EpiPen Jr® Auto-Injectors
- Trileptal® (oxcarbazepine) – New contraindication and warning
- Cubicin®/Cubicin® RF (daptomycin) – Expanded indication
- Ibrance® (palbociclib) – Expanded indication, label update
- Orencia® (abatacept) – Expanded indication
- Qudexy® XR (topiramate) – New indication
- Austedo™ (deutetrabenazine) – New orphan drug approval
- Quartette® (levonorgestrel/ethinyl estradiol) – First-time generic
- Tazorac® (tazarotene) – First-time generic
- Sovaldi® and Harvoni® – Expanded indications
- Trokendi XR® (topiramate) – New indication
- Shire – Recall of Kalbitor® (ecallantide)
- Ingrezza™ (valbenazine) – New drug approval
- HIV and hepatitis B medications – Updated boxed warnings
- Erythropoiesis-stimulating agents – REMS removal
- Lucentis® (ranibizumab) – New indication
- C.O. Truxton – Recall of phenobarbital
- Hospira – Recall of dextrose 25% injection
- AirDuo™ RespiClick® (fluticasone/salmeterol) – New drug and first-time generic launch
- Renflexis™ (infliximab-abda) – New biosimilar approval
- Codeine and tramadol – New contraindications and warnings
- Tecentriq® (atezolizumab) – Expanded indication
- Thymoglobulin® [anti-thymocyte globulin (rabbit)] – Expanded indication
- Alunbrig™ (brigatinib) – New orphan drug approval
- Brineura™ (cerliponase alfa) – New orphan drug approval
- Imfinzi™ (durvalumab) – New drug approval
- RoxyBond™ (oxycodone) – New drug approval
- Rydapt® (midostaurin) – New orphan drug approval
- Tymlos™ (abaloparatide) – New drug approval
- Xatmep™ (methotrexate) – New drug approval
- Vytorin® (ezetimibe/simvastatin) – First-time generic
- Keppra®/Keppra XR® (levetiracetam) – New warning
- Bunavail® (buprenorphine/naloxone) – Expanded indication
- Opdivo® (nivolumab) – Expanded indication
- Praluent® (alirocumab) – New dosing regimen
- Ravicti® (glycerol phenylbutyrate) – Expanded indication
- Stivarga® (regorafinib) – New orphan indication
- C.O. Truxton – Recall of phenobarbital and amitriptyline
- Radicava™ (edaravone) – New orphan drug approval
- Zosyn® (piperacillin/tazobactam) – New warning
- Bavencio® (avelumab) – New indication
- RxOutlook - 2nd Quarter 2017
- Rescriptor® (delavirdine mesylate) – Product discontinuation
- Minolira™ (minocycline) – New drug approval
- Lysodren® (mitotane) – New warning
- Keytruda® (pembrolizumab) – Expanded indication
- Jadenu® Sprinkle (deferasirox) – New formulation approval
- Kevzara® (sarilumab) – New drug approval
- Clolar® (clofarabine) – First-time generic
- Canagliflozin – New boxed warning
- Fareston® (toremifene) – New warnings
- Pletal® (cilostazol) – New warning
- Sensipar® (cinacalcet) – New warning
- Yondelis® (trabectedin) – New warning
- Actemra® (tocilizumab) – New indication
- Baxter – Recall of fluconazole and milrinone injection
- Kalydeco® (ivacaftor) – Expanded indication
- Keytruda® (pembrolizumab) – New indications
- Penicillin G Procaine – Drug shortage
- AstraZeneca – Recall of Brilinta® (ticagrelor)
- Lupin – Recall of Mibelas™ 24 Fe (norethindrone/ethinyl estradiol and ferrous fumarate)
- Sensipar® (cinacalcet) – New warning
- Keytruda® (pembrolizumab) – New indication
- Syndros® (dronabinol) – Schedule change
- Zykadia® (ceritinib) – Expanded indication
- BD – Recall of BD insulin syringes
- Isentress® HD (raltegravir) – New formulation approval
- Rebinyn® (coagulation factor IX [recombinant] glycoPEGylated) – New drug approval
- Zerviate™ (cetirizine) – New drug approval
- Butrans® (buprenorphine) – First-time generic
- Strattera® (atomoxetine) – First-time generic
- Opana® ER (oxymorphone) – Request for market removal
- Bristol-Myers Squibb – Recall of Eliquis® (apixaban)
- Aristada® (aripiprazole lauroxil) – New formulation approval
- Fibryna® (fibrinogen [human]) – New drug approval
- Norvir® (ritonavir) – New formulation approval
- Pataday® (olopatadine) – First-time Generic
- Truvada® (emtricitabine/tenofovir disoproxil fumarate) – First-time Generic
- Biaxin®/Biaxin® XL (clarithromycin) – New warning
- Teva – Recall of paliperidone
- Bristol-Myers Squibb – Update to recall of Eliquis® (apixaban)
- Baxdela™ (delafloxacin) – New drug approval
- Cotempla XR-ODT™ (methylphenidate) – New drug approval
- Symjepi™ (epinephrine) – New drug approval
- Acticlate® (doxycycline hyclate) – First-time generic
- Lialda® (mesalamine) – First-time generic
- Darzalex® (daratumumab) – Expanded indication
- Dysport® (abobotulinumtoxinA) – Expanded indication
- Ionsys® (fentanyl iontophoretic) – Product discontinuation
- Bevyxxa™ (betrixaban) – New drug approval
- Haegarda® (C1 esterase inhibitor [human]) – New orphan drug approval
- Mydayis™ (mixed salts of a single-entity amphetamine product) – New drug approval
- Rituxan Hycela™ (rituximab and hyaluronidase human) – New drug approval
- Tafinlar® (dabrafenib) and Mekinist® (trametinib) – New indication
- Triptodur™ (triptorelin) – New drug approval
- Axiron® (testosterone) – First-time generic
- Otezla® (apremilast) – New warning
- Aerospan® (flunisolide) – Revised indication
- Vectibix® (panitumumab) – Expanded indication
- Novo Nordisk – Recall of NovoPen Echo® insulin cartridge holder
- Baxter – Recall of 0.9% sodium chloride injection and 5% dextrose injection
- DepoCyt® (cytarabine liposome) – Drug discontinuation
- Opana® ER (oxymorphone) – Market withdrawal
- Endari™ (L-glutamine) – New orphan drug approval
- Alkeran® (melphalan) – First-time generic
- Vigamox® (moxifloxacin) – First-time generic
- Orencia® (abatacept) – New indication
- Vimovo® (esomeprazole magnesium/naproxen) – New and expanded indications
- Vosevi™ (sofosbuvir/velpatasvir/voxilaprevir) – New drug approval
- Potiga® (ezogabine) – Drug discontinuation
- Nerlynx™ (neratinib) – New drug approval
- Tremfya™ (guselkumab) – New drug approval
- Zypitamag™ (pitavastatin) – New drug approval
- Blincyto® (blinatumomab) – Expanded indication
- Benlysta® (belimumab) – New formulation approval
- Aralen® (chloroquine) – New warnings
- ICU Medical – Recall of 0.9% sodium chloride injection
- Tanzeum® (albiglutide) – Drug discontinuation
- Idhifa® (enasidenib) – New orphan drug approval
- Nityr (nitisinone) – New drug approval
- Epiduo® (adapalene/benzoyl peroxide) – First-time generic
- Relpax® (eletriptan) – First-time generic
- Transderm Scop® (scopolamine) – First-time Generic
- Keytruda® (pembrolizumab) – New warnings
- Abilify Maintena® (aripiprazole) – New indication
- Fycompa® (perampanel) – Expanded indication
- Kalydeco® (ivacaftor) – Expanded indication
- Yervoy® (ipilimumab) – Expanded indication
- Mavyret™ (glecaprevir/pibrentasvir) – New drug approval
- QVAR® Redihaler™ (beclomethasone dipropionate HFA) – New formulation approval
- Epclusa® (sofosbuvir/velpatasvir) – Expanded indication
- Imbruvica® (ibrutinib) – New indication
- Liletta® (levonorgestrel-releasing intrauterine system) – Expanded indication
- Opdivo® (nivolumab) – New indication
- PharmaTech – Recall of liquid products
- International Laboratories – Recall of pravastatin
- PharmaTech – Recall update
- Amneal – Recall of lorazepam oral concentrate
- RxOutlook - 3rd Quarter 2017
- Vyxeos™ (daunorubicin/cytarabine) – New orphan drug approval
- Tolmetin – Drug shortage
- CaroSpir® (spironolactone) – New drug approval
- Nikita® (pitavastatin) – New drug approval
- Cancidas® (caspofungin acetate) – First-time generic
- Effient® (prasugrel) – First-time Generic
- Fosrenol® (lanthanum carbonate) – First-time generic
- Januvia® (sitagliptin), Janumet®, Janumet XR (sitagliptin/metformin), Jentadueto®, Jentadueto XR (linagliptin/metformin), Tradjenta® (linagliptin), Glyxambi® (linagliptin/empagliflozin) – New warning
- QVAR® (beclomethasone dipropionate) – Drug discontinuation
- Besponsa™ (inotuzumab ozogamicin) – New orphan drug approval
- Duzallo® (lesinurad/allopurinol) – New drug approval
- Lynparza® (olaparib) – New formulation approval
- Tysabri® (natalizumab) – New warning
- Sage Products – Recall of oral care products
- Cyltezo™ (adalimumab-adbm) – New biosimilar approval
- Gocovri™ (amantadine) – New drug approval
- Kedrab™ (rabies immune globulin [human]) – New drug approval
- Prograf® (tacrolimus) – First-time generic
- Sabril® (vigabatrin) – First-time generic
- Victoza® (liraglutide) – New indication, new warning
- Faslodex® (fulvestrant) – Expanded indication
- Mid Valley Pharmaceutical – Recall of Doctor Manzanilla products
- Lucky Mart – Recall of Piyanping Anti-Itch Lotion
- Kymriah™ (tisagenlecleucel) – New drug approval
- Benznidazole – New orphan drug approval
- Mylotarg™ (gemtuzumab ozogamicin) – New orphan drug approval
- Vabomere™(meropenem/vaborbactam) – New drug approval
- Foshan Flying Medical Products – Product safety alert
- Actemra® (tocilizumab) – New orphan indication
- Austedo® (deutetrabenazine) – New indication
- Medtronic – Recall of Diabetes Infusion Sets
- Tracleer® (bosentan) – New formulation approval
- Safyral® (drospirenone/ethinyl estradiol/ levomefolate) – First-time generic
- Gleevec® (imatinib) – New warning
- Kayexalate® (sodium polystyrene sulfonate) – Safety update
- Afluria® Quadrivalent (influenza vaccine) – Expanded indication
- Cubicin®/Cubicin® RF(daptomycin) – Expanded indication
- Mvasi™ (bevacizumab-awwb) – New biosimilar approval
- Adzenys ER™ (amphetamine) – New formulation approval
- Aliqopa™ (copanlisib) – New orphan drug approval
- Solosec™ (secnidazole) – New drug approval
- Tamiflu® (oseltamivir phosphate) oral suspension – First-time generic
- Privigen® (immune globulin intravenous [human], 10%) – New indication, new warning
- Aptiom® (eslicarbazepine) – Expanded indication, new warning
- Briviact® (brivaracetam) – Expanded indication
- Opioid cough suppressants in children – FDA Advisory Committee Recommendations
- Somatuline® Depot (lanreotide) – New indication
- Symbicort® (budesonide/formoterol) – Updated indication
- Trelegy™ Ellipta® (fluticasone furoate/ umeclidinium/vilanterol) – New drug approval
- Xhance™ (fluticasone propionate) – New drug approval
- Brisdelle® (paroxetine mesylate) – First-time generic
- Buphenyl® (sodium phenylbutyrate) – First-time generic
- Ziagen® (abacavir) oral solution – First-time generic
- Lexiva® (fosamprenavir) – First-time generic
- Ocaliva® (obeticholic acid) – Safety Communication
- Revlimid® (lenalidomide) – New warning
- Zelboraf® (vemurafenib) – New warning
- Keytruda® (pembrolizumab) – New indication
- Opdivo® (nivolumab) – New indication
- Rapivab™ (peramivir) – Expanded indication
- Fiasp® (insulin aspart) – New drug approval
- Prolastin®-C Liquid (alpha1-proteinase inhibitor [human]) – New formulation approval
- Verzenio™ (abemaciclib) – New drug approval
- Immediate-release opioids – Safety update
- Vancomycin injection – New warning
- Descovy® (emtricitabine/tenofovir alafenamide) – Expanded indication
- Genvoya® (elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide) – Expanded indication
- Baxter – Recall of Intralipid® 20% (intravenous [IV] fat emulsion)
- Ascor® (ascorbic acid) – New drug approval
- Zilretta™ (triamcinolone acetonide) – New drug approval
- Avelox® (moxifloxacin) – First-time generic
- Copaxone® (glatiramer) – First-time generic
- Epogen®/Procrit® (epoetin alfa) – New warnings
- Lemtrada® (alemtuzumab) – New warning
- Lomotil® (atropine/diphenoxylate) – Revised indication and new contraindication
- Promacta® (eltrombopag) – New warning
- QVAR® (beclomethasone dipropionate HFA) – Revised indication
- Octapharma – Withdrawal of Octagam® [immune globulin intravenous (human) 10% liquid preparation]
- Lyrica® CR (pregabalin) – New formulation approval
- Trimpex™ (trimethoprim) – New drug approval
- Alimta® (pemetrexed) – New warnings
- DuoDote® (atropine/pralidoxime) – Expanded indication
- Stelara® (ustekinumab) – Expanded indication
- Purdue Recall – Betadine® Solution Swabstick
- Bydureon® BCise™ (exenatide extended-release) – New formulation approval
- Zecuity® (sumatriptan iontophoretic transdermal system) – Product Discontinuation
- Shingrix™ (zoster vaccine recombinant, adjuvanted) – New drug approval
- Yescarta™ (axicabtagene ciloleucel) – New orphan drug approval
- Aczone® (dapsone) – First-time generic
- Reyataz® (atazanavir) – New warning, label updates
- Pegasys® (peginterferon alfa-2a) – Expanded indication
- Simponi Aria® (golimumab) – New indications
- Calquence® (acalabrutinib) – New drug approval
- Varubi® (rolapitant) injectable emulsion – New formulation approval
- Prevacid®, Prevacid® SoluTab™ (lansoprazole) – New warnings
- Remicade® (infliximab) – New warning
- Oxytrol® (oxybutynin) – Updated indication
- Soliris® (eculizumab) – New indication
- Xarelto® (rivaroxaban) – Expanded indication
- Fresenius Kabi – Recall of midazolam injection
- Owen Mumford – Recall of Unifine® Pentips®
- Vyzulta™ (latanoprostene bunod) – New drug approval
- Alecensa® (alectinib) – Expanded indication, new warning
- Aranesp® (darbepoetin alfa) – New warning
- Auryxia® (ferric citrate) – New indication
- Vimpat® (lacosamide) – Expanded indication
- Xtampza® ER (oxycodone) – Label updates
- Zelboraf® (vemurafenib) – New indication
- Aminocaproic acid injection, Epinephrine injection, Molindone tablets – Drug shortages
- RxOutlook - 4th Quarter 2017
- Baxter – Recall of Nexterone injection
- Cinvanti™ (aprepitant) – New drug approval
- Heplisav-B™ (hepatitis B vaccine) – New drug approval
- Prevymis™ (letermovir) – New orphan drug approval
- Coreg CR® (carvedilol) – First-time generic
- Adcetris® (brentuximab vedotin) – New indication
- American College of Cardiology/American Heart Association – Guideline update for the management of hypertension
- Sprycel® (dasatinib) – Expanded orphan indication
- Vraylar™ (cariprazine) – Expanded indication
- Greenstone – Recall of diphenoxylate/atropine
- Abilify MyCite® (aripiprazole tablets with sensor) – New drug approval
- Fasenra™ (benralizumab) – New drug approval
- Mepsevii™ (vestronidase alfa-vjbk) – New orphan drug approval
- Uloric® (febuxostat) – Safety update
- Faslodex® (fulvestrant) – Expanded indication
- Baxter – Recall of sodium chloride injection
- Sun Pharmaceuticals – Recall of Riomet® (metformin)
- Recombivax HB®, YF-Vax® – Drug shortages
- Hemlibra® (emicizumab-kxwh) – New orphan drug approval
- Juluca® (dolutegravir/rilpivirine) – New drug approval
- Tekturna® (aliskiren) – Expanded indication and new formulation
- Locoid® (hydrocortisone butyrate) 0.1% lotion – First-time generic
- Treximet® (sumatriptan/naproxen) – First-time generic
- Gazyva® (obinutuzumab) – Expanded indication and new warning
- Tivicay® (dolutegravir) – Expanded indication, new warnings
- Triumeq® (abacavir/dolutegravir/lamivudine) – Expanded indication, new warnings
- Auvi-Q® (epinephrine) – Expanded indication
- Isentress® (raltegravir) – Expanded indication
- Sutent® (sunitinib malate) – New indication
- Simple Diagnostics – Recall of Alcohol Prep Pads
- Clenpiq™ (sodium picosulfate/magnesium oxide/anhydrous citric acid) – New drug approval
- Impoyz™ (clobetasol propionate) – New drug approval
- Klor-Con® (potassium chloride) powder – New formulation approval
- Ogivri™ (trastuzumab-dkst) – New biosimilar approval
- Sublocade™ (buprenorphine, extended-release) – New drug approval
- Istalol® (timolol maleate) – First-time generic
- Tygacil® (tigecycline) – First-time generic
- Keytruda® (pembrolizumab) – New warning
- Limbrel250® and Limbrel500® – Safety communication
- Pomalyst® (pomalidomide), Revlimid® (lenalidomide), Thalomid® (thalidomide) – New warning
- Repatha® (evolocumab) – New and expanded indications
- Taltz® (ixekizumab) – New indication
- Admelog® (insulin lispro) – New drug approval
- Lonhala™ Magnair™ (glycopyrrolate) – New drug approval
- Ozempic® (semaglutide) – New drug approval
- Sinuva™ (mometasone furoate) – New drug approval
- Xepi™ (ozenoxacin) – New drug approval
- Kenalog®- 40 (triamcinolone acetonide) – First-time generic
- Viagra® (sildenafil) – First-time generic
- B. Braun Medical – Recall of Acetic Acid Irrigation
- Luxturna™ (voretigene neparvovec-rzyl) – New orphan drug approval
- Eskata™ (hydrogen peroxide) – New drug approval
- Ifixi® (infliximab-qbtx) – New biosimilar approval
- Cosmegen® (dactinomycin) – First-time generic
- Viread® (tenofovir disoproxil fumarate) – First-time generic
- Nucala® (mepolizumab) – New orphan indication
- Omidria® (phenylephrine/ketorolac) – Expanded indication
- Xeljanz®/Xeljanz® XR (tofacitinib) – New indication
- AuroMedics Pharma – Recall of Linezolid Injection
- Giapreza™ (angiotensin) – New drug approval
- Prexxartan® (valsartan) – New drug approval
- Rhopressa® (netarsudil) – New drug approval
- Steglatro™ (ertugliflozin), Steglujan™ (ertugliflozin/sitagliptin), Segluromet™ (ertugliflozin/metformin) – New drug approval
- Gilenya® (fingolimod) – New warning
- Long-acting beta agonists (LABAs) used in combination with inhaled corticosteriods (ICS) – Safety Update
- Bosulif® (bosutinib) – Expanded indication
- Cabometyx® (cabozantinib) – Expanded indication
- Opdivo® (nivolumab) – Expanded indication
- Perjeta® (pertuzumab) – Expanded indication
- Lumify™ (brimonidine) – New over-the-counter drug approval
- Siklos™ (hydroxyurea) – New orphan drug approval
- Estrace® (estradiol) – First-time generic
- Reyataz® (atazanavir) – First-time generic
- Sustiva® (efavirenz) – First-time generic
- Procysbi® (cysteamine bitartrate) – Expanded indication
- Xgeva® (denosumab) – Expanded indication
- International Laboratories – Recall of clopidogrel
- Jevtana® (cabazitaxel) – New warning
- Prescription Cough and Cold Medicines – Safety Updates
- Istodax® (romidepsin) – First-time generic
- Fluarix® Quadrivalent (influenza vaccine) – Expanded indication
- Gilotrif® (afatinib) – Expanded indication
- Lynparza® (olaparib) – New indication
- Fresenius Kabi – Recall of vecuronium injection
- Magno-Humphries Laboratories – Recall of Senna Laxative
- Balcoltra™ (levonorgestrel/ethinyl estradiol/ferrous bisglycinate) – New drug approval
- Trisenox® (arsenic trioxide) – New indication
- Primus Pharmaceuticals – Recall of Limbrel®
- Aerospan® (flunisolide) – Product Discontinuation
- Firvanq™ (vancomycin) – New drug approval
- Lutathera® (lutetium Lu 177 dotatate) – New orphan drug approval
- Videx® and Videx® EC – Updated boxed warning and contraindications
- Xgeva® (denosumab) – New warning
- Trulance® (plecanatide) – New indication
- Kareway Products – Recall of Gericare® Eye Wash
- Aminocaproic acid injection – Drug shortage
- Sustiva® (efavirenz) – First-time generic
- Imodium® (loperamide) – Safety communication
- Ocaliva® (obeticholic acid) – New boxed warning
- Avycaz® (ceftazidime/avibactam) – New indication
- Erelzi™ (etanercept-szzs) – Indication removals
- Zomacton® (somatropin) – Expanded indication
- RxHighlights - January 2018 Edition
- Symdeko™ (tezacaftor/ivacaftor and ivacaftor) – New drug approval
- Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide) – New drug approval
- Dexycu™ (dexamethasone intraocular suspension) – New drug approval
- HyperRAB® (rabies immune globulin [human]) – New formulation
- Symfi Lo™ (efavirenz/lamivudine/tenofovir disoproxil fumarate) – New drug approval
- Syprine® (trientine) – First-time generic
- Exondys 51™ (eteplirsen) – New warning
- Uloric® (febuxostat) – New warning
- Feraheme® (ferumoxytol) – Expanded indication
- Zytiga® (abiraterone acetate) – Expanded indication
- RxOutlook - 1st Quarter 2018
- B. Braun Medical – Recall of sodium chloride irrigation
- Erleada™ (apalutamide) – New drug approval
- Makena® (hydroxyprogesterone caproate) – New formulation
- Osmolex ER™ (amantadine) – New drug approval
- Rexulti® (brexpiprazole) – New warning
- Imfinzi® (durvalumab) – New indication
- Apadaz™ (benzhydrocodone/acetaminophen) – New drug approval
- Imbruvica® (ibrutinib) – New formulation approval
- Namenda XR® (memantine) – First-time generic
- Biaxin® (clarithromycin) – New warning
- Norditropin® FlexPro (somatropin) – New indications and updated warnings
- Luzu® (luliconazole) – Expanded indication
- Verzenio™ (abemaciclib) – Expanded indication
- RxHighlights - February 2018 Edition
- Sagent – Recall of methylprednisolone injection
- Sumavel® DosePro® (sumatriptan) – Product discontinuation
- Zinbryta® (daclizumab) – Drug withdrawal
- Cimduo™ (lamivudine/tenofovir disoproxil fumarate) – New drug approval
- ZTlido™ (lidocaine topical system) – New drug approval
- Otiprio® (ciprofloxacin otic suspension) – New Indication
- Trogarzo™ (ibalizumab-uiyk) – New orphan drug approval
- Latuda® (lurasidone) – Expanded indication
- Prevacid® SoluTab™ (lansoprazole) – First-time generic
- Praluent® (alirocumab) – ODYSSEY Outcomes study results
- Bayer – Recall of Alka-Seltzer Plus® products
- Norvir® (ritonavir) – First-time generic
- Adcetris® (brentuximab vedotin) – New indication
- Hizentra® (immune globulin subcutaneous [human], 20%) – New orphan indication
- Ilumya™ (tildrakizumab-asmn) – New drug approval
- Symfi™ (efavirenz/lamivudine/tenofovir disoproxil fumarate) – New drug approval
- Aloxi® (palonosetron) – First-time generic
- Tasigna® (nilotinib) – New and expanded indications, new warning
- Leukine® (sargramostim) – New indication, safety updates
- Blincyto™ (blinatumomab) – Expanded orphan indication
- AuroMedics – Recall of levetiracetam, levofloxacin and linezolid injection products
- Progesterone injection – Drug shortage
- Diprolene®/ Diprolene® AF (augmented betamethasone dipropionate) – New warning
- Solu-Medrol® (methylprednisolone sodium succinate) – New contraindication and warning
- Emend™ (fosaprepitant) – Expanded indication
- Rubraca® (rucaparib) – New indication
- RxHighlights - March 2018 Edition
- MHC Medical Products – Recall of Easy Touch® Insulin Syringe
- Talwin™ (pentazocine) – Product discontinuation
- Crysvita® (burosumab-twza) – New orphan drug approval
- Afinitor Disperz® (everolimus) – Expanded indication
- Exparel® (bupivacaine) – New indication
- Opdivo® (nivolumab) and Yervoy® (ipilimumab) – New indication
- Olysio® (simeprevir) – Drug discontinuation
- Akynzeo® (fosnetupitant/palonosetron) – New formulation
- Tavalisse™ (fostamatinib) – New drug approval
- Biltricide® (praziquantel) – First-time generic
- Zavesca® (miglustat) – First-time generic
- Samsca® (tolvaptan) – Safety update
- Viberzi® (eluxadoline) – New warning
- Tagrisso® (osimertinib) – New Indication
- Vonvendi® [von Willebrand factor (recombinant)] – Expanded indication
- BD Medical – Recall of heparin lock flush and normal saline syringes
- MHC Medical Products – Recall of Easy Touch® Insulin Syringe
- Bydureon® (exenatide) – Product discontinuation
- Jynarque™ (tolvaptan) – New orphan drug approval
- Lamictal® (lamotrigine) – Safety communication
- Kymriah™ (tisagenlecleucel) – New indication
- Trelegy® Ellipta® (fluticasone furoate/umeclidinium/vilanterol) – Expanded indication
- RxHighlights - April 2018 Edition
- AuroMedics – Recall of ampicillin/sulbactam and piperacillin/tazobactam injection products
- RxOutlook - 2nd Quarter 2018
- Andexxa® (coagulation factor Xa [recombinant], inactivated-zhzo) – New orphan drug approval
- Plenvu® (polyethylene glycol 3350/sodium ascorbate/sodium sulfate/ascorbic acid/sodium chloride/potassium chloride) – New drug approval
- Lyrica® (pregabalin) – Expanded indication
- Myrbetriq® (mirabegron) – Expanded indication
- Tafinlar® (dabrafenib) and Mekinist® (trametinib) – New indication
- Tafinlar® (dabrafenib) and Mekinist® (trametinib) – New orphan indication
- Apotex – Recall of piperacillin/tazobactam injection
- Roche – Recall of Accu-Chek® Aviva Plus Test Strips
- Retacrit™ (epoetin alfa-epbx) – New biosimilar approval
- Darzalex® (daratumumab) – Expanded indication
- Gilenya® (fingolimod) – Expanded indication
- Aimovig™ (erenumab-aooe) – New drug approval
- Truvada® (emtricitabine/tenofovir disoproxil fumarate) – Expanded Indication
- Briviact® (brivaracetam) – Expanded Indication
- Keytruda® (pembrolizumab), Tecentriq® (atezolizumab) – Safety Communication
- Dolutegravir-Containing Products – Safety Communication
- Mephyton® (phytonadione) – First-time Generic
- Lokelma™ (sodium zirconium cyclosilicate) – New Drug Approval
- Doptelet® (avatrombopag) – New Drug Approval
- Allergan – Recall of Taytulla® (norethindrone acetate/ethinyl estradiol and ferrous fumarate)
- Technivie™ (ombitasvir/paritaprevir/ritonavir) and Viekira XR™ (dasabuvir/ombitasvir/paritaprevir/ritonavir) – Product discontinuations
- Palynziq™ (pegvaliase-pqpz) – New drug approval
- Yonsa® (abiraterone) – New drug approval
- Oral Benzocaine Products – Safety Communication
- Arnuity® Ellipta® (fluticasone furoate) – Expanded Indication
- Cimzia® (certolizumab pegol) – New Indication
- Prolia® (denosumab) – New Indication
- Apotex – Recall of fluticasone propionate nasal spray
- Consensi® (amlodipine/celecoxib) – New Drug Approval
- Fulphila™ (pegfilgrastim-jmdb) – New Biosimilar Approval
- Imvexxy™ (estradiol vaginal inserts) – New Drug Approval
- Olumiant® (baricitinib) – New Drug Approval
- Prograf® (tacrolimus) – New Formulation
- Alimta® (pemetrexed) – Expanded Indication
- Xeljanz® (tofacitinib) – New Indication
- ICU Medical – Recall of Intravenous Solutions
- RxHighlights - May 2018 Edition
- Lenvima® (lenvatinib) – New Warning
- Proton Pump Inhibitors – New Warning
- Mircera® (methoxy polyethylene glycol-epoetin beta) – New Indication
- Rituxan® (rituximab) – New Orphan Indication
- Venclexta® (venetoclax) – Expanded Indication
- Grifols – Recall of Profilnine®, Factor IX Complex
- Moxidectin – New orphan Drug Approval
- Suboxone® (buprenorphine/naloxone) – First-time generic
- Remodulin® (treprostinil) – New Warnings
- Stelara® (ustekinumab) – New warning
- Avastin® (bevacizumab) – Expanded Indication
- Keytruda® (pembrolizumab) – New Indication
- Keytruda® (pembrolizumab) – New Indication
- Depen® (penicillamine) – Drug Shortage
- Epidiolex® (cannabidiol) – New Drug Approval
- LymePak™ (doxycycline hyclate) – New Drug Approval
- Nocdurna® (desmopressin acetate) – New Drug Approval
- Neupogen® (filgrastim) and Neulasta® (pegfilgrastim) – New Warning
- Cinryze® (C1 esterase inhibitor [human]) – Expanded indication
- Keytruda® (pembrolizumab) – Expanded Indication
- Tecentriq® (atezolizumab) – Expanded Indication
- Aristada Initio™ (aripiprazole lauroxil) – New Drug Approval
- Braftovi™ (encorafenib) and Mektovi® (binimetinib) – New Drug Approval
- Nuplazid® (pimavanserin) – New Formulation
- Qbrexza™ (glycopyrronium) – New Drug Approval
- Zemdri™ (plazomicin) – New Drug Approval
- Invanz® (ertapenem) – First-time Generic
- Makena® (hydroxyprogesterone caproate) – First-time Generic
- RxHighlights - June 2018 Edition
- Clindagel® (clindamycin phosphate) – First-time Generic
- Luzu™ (luliconazole) – First-time Generic
- Uceris® (budesonide) – First-time Generic
- Lamictal® (lamotrigine) – New Warning
- Signifor® LAR (pasireotide) – New Indication
- Xeomin® (incobotulinumtoxinA) – New Indication
- Major, Solco Healthcare, and Teva – Recall of Valsartan and Valsartan/Hydrochlorothiazide Products
- Glyrx-PF™ (glycopyrrolate)– New drug approval
- TPOXX® (tecovirimat) – New drug approval
- Fluoroquinolone Antibiotics – Warning updates
- Xtandi® (enzalutamide) – Expanded indication and new warnings
- Opdivo® (nivolumab) and Yervoy® (ipilimumab) – Expanded indication
- AvKARE – Recall of Valsartan/Hydrochlorothiazide
- Vaniqa™ (eflornithine) – Drug shortage
- Infugem™ (gemcitabine) – New drug approval
- Krintafel™ (tafenoquine) – New drug approval
- Nivestym™ (filgrastim-aafi) – New biosimilar approval
- Symtuza™ (darunavir/cobicistat/emtricitabine/tenofovir alafenamide) – New drug approval
- Tibsovo® (ivosidenib) – New orphan drug approval
- Veltin® (clindamycin phosphate/tretinoin) – First-time generic
- Welchol® (colesevelam hydrochloride) – First time generic
- Kisqali® (ribociclib) – Expanded indications and new warning
- Intelence® (etravirine) – Expanded indication
- Zomacton® (somatropin) – New indications
- Valsartan and Valsartan-HCTZ Products – Recall and Safety Update
- Valsartan and Valsartan-HCTZ Products – Recall Update
- Azedra® (iobenguane I 131) – New orphan drug approval
- Orilissa™ (elagolix) – New drug approval
- Perseris™ (risperidone) – New drug approval
- Topicort® (desoximetasone) – First-time generic
- Atripla® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) – Expanded indication and new contraindication
- Valsartan and Valsartan-HCTZ Products – Recall Update
- Nuvessa™ (metronidazole) – Expanded indication
- Lotemax® (loteprednol etabonate) – Expanded indication
- Granix® (tbo-filgrastim) – Expanded indication and new warnings
- Azithromycin – Safety Update
- Remodulin® (treprostinil) – New formulation approval
- Mulpleta® (lusutrombopag) – New drug approval
- Camber and NuCare – Recall of Valsartan
- RxHighlights - July 2018 Edition
- RxOutlook - 3rd Quarter 2018
- AvKARE – Recall of Valsartan
- AzaSite® (azithromycin), Belladonna and Opium Suppository – Drug shortages
- Annovera™ (segesterone acetate/ethinyl estradiol) – New drug approval
- Arakoda™ (tafenoquine) – New drug approval
- Galafold™ (migalastat) – New orphan drug approval
- Jornay PM™ (methylphenidate) – New drug approval
- Orkambi® (lumacaftor/ivacaftor) – Expanded indication and New formulation approval
- Poteligeo® (mogamulizumab-kpkc) – New orphan drug approval
- Onpattro™ (patisiran) – New orphan drug approval
- Adcirca® (tadalafil) – First-time generic
- Cosopt® PF (dorzolamide/timolol) – First-time generic
- Torrent – Recall of Amlodipine/Valsartan/Hydrochlorothiazide
- CEQUA™ (cyclosporine) – New drug approval
- lamivudine/nevirapine/zidovudine – New drug approval
- Torisel® (temsirolimus) – First-time generic
- Kalydeco® (ivacaftor) – Expanded indication
- Lenvima® (lenvatinib) – New indication
- Prepopik® (sodium picosulfate/magnesium oxide/anhydrous citric acid) – Expanded indication
- Torrent – Recall of Valsartan-Containing Products
- Grifols – Withdrawal of Gamunex®-C (immune globulin [human])
- Valsartan-Containing Products – Recall Update
- Accord Healthcare – Recall of Hydrochlorothiazide
- Erythrocin™(erythromycin lactobionate), Marplan® (isocarboxazid) – Drug shortages
- Diacomit® (stiripentol) – New orphan drug approval
- Altreno™ (tretinoin) – New drug approval
- Inveltys™ (loteprednol etabonate) – New drug approval
- Oxervate™ (cenegermin-bkbj) – New orphan drug approval
- Takhzyro™ (lanadelumab-flyo) – New orphan drug approval
- Riomet® (metformin) – First-time generic
- Zyclara® (imiquimod) – First-time generic
- Imbruvica® (ibrutinib) – Expanded indication
- Keytruda® (pembrolizumab) – Expanded indication
- Opdivo® (nivolumab) – New indication
- Camber – Recall of Montelukast
- Delstrigo™ (doravirine/lamivudine/tenofovir disoproxil fumarate) and Pifeltro™ (doravirine) – New drug approvals
- Jivi® (antihemophilic factor (recombinant), PEGylated-aucl) – New drug approval
- Xerava™ (eravacycline) – New drug approval
- Sodium-glucose cotransporter-2 (SGLT-2) inhibitors – New warning
- Trividia Health – Recall of Insulin Syringes
- RxHighlights - August 2018 Edition
- Tiglutik™ (riluzole) – New orphan drug approval
- Lynparza™ (olaparib) – Product discontinuation
- Dolutegravir-containing products – New warning
- Ajovy™ (fremanezumab-vfrm) – New drug approval
- Valsartan Recall – Update
- Daklinza™ (daclatasvir) – Product Discontinuation
- Scopolamine transdermal system – Product discontinuation
- Cassipa® (buprenorphine/naloxone) – New drug approval
- Lumoxiti™ (moxetumomab pasudotox-tdfk) – New orphan drug approval
- Xelpros™ (latanoprost ophthalmic emulsion) – New formulation approval
- Ampyra® (dalfampridine) – First-time generic
- BiCNU® (carmustine) – First-time generic
- Actemra® (tocilizumab) – New indication
- Copiktra™ (duvelisib) – New orphan drug approval
- Albenza® (albendazole) – First-time generic
- Sporanox® (itraconazole) – First-time generic
- Immediate-release opioids – Safety update
- Emgality™ (galcanezumab-gnlm) – New drug approval
- Endo International – Recall of Robaxin® (methocarbamol)
- Hexalen® (altretamine) – Product discontinuation
- Arikayce® (amikacin liposome inhalation suspension) – New orphan drug approval
- Libtayo® (cemiplimab-rwlc) – New drug approval
- Vizimpro® (dacomitinib) – New orphan drug approval
- Cialis® (tadalafil) – First-time generic
- Forfivo XL® (bupropion) – First-time generic
- Evekeo® (amphetamine) – First-time generic
- Coagadex® (coagulation Factor X [human]) – New and expanded indications
- Fycompa® (perampanel) – Expanded indication
- Humira® (adalimumab) – Expanded orphan indication
- RxHighlights - September 2018 Edition
- ReoPro® (abciximab) – Drug Shortage
- Mustargen® (mechlorethamine) – Product discontinuation
- Nuzyra™ (omadacycline) – New drug approval
- Revcovi™ (elapegademase-lvlr) – New orphan drug approval
- Seysara™ (sarecycline) – New drug approval
- Symjepi™ (epinephrine) – New formulation approval
- Tegsedi™ (inotersen) – New orphan drug approval
- Xyosted™ (testosterone enanthate) – New formulation approval
- Kristalose® (lactulose) – First-time generic
- Gardasil® 9 (HPV 9-valent vaccine, recombinant) – Expanded indication
- Hemlibra® (emicizumab-kxwh) – Expanded indication
- ICU Medical – Recall of Intravenous Solutions
- Xarelto® (rivaroxaban) – New indication
- Erwinaze® (asparginase Erwinia chrysanthemi) – Drug Shortage
- AndroGel® (testosterone) 1.62% – First-time generic
- Taxotere® (docetaxel) – New warning
- Aminophylline Injection – Drug Shortage
- Talzenna® (talazoparib) – New drug approval
- Onfi® (clobazam) – First-time generic
- Dupixent® (dupilumab) – New indication and new warnings
- Humira® (adalimumab) – Expanded indication
- Liletta® (levonorgestrel-releasing intrauterine system) – Expanded indication
- ScieGen Pharmaceuticals – Recall of Irbesartan Update
- Xyrem® (sodium oxybate) – Expanded indication
- Bijuva™ (estradiol/progesterone) – New drug approval
- Khapzory™ (levoleucovorin) – New Drug Approval
- Qmiiz ODT™ (meloxicam) – New drug approval
- Xofluza™ (baloxavir marboxil) – New drug approval
- Sodium phosphate injection – Drug shortage
- Dsuvia™ (sufentanil) – New drug approval
- Hyrimoz™ (adalimumab-adaz) – New biosimilar approval
- Lorbrena® (lorlatinib) – New orphan drug approval
- Sympazan™ (clobazam) – New drug approval
- Udenyca™ (pegfilgrastim-cbqv) – New biosimilar approval
- Levitra® (vardenafil) – First-time generic
- Minivelle® (estradiol) – First-time generic
- EpiPen® (epinephrine) – Safety communication
- Invokana® (canagliflozin) – New indication
- Keytruda® (pembrolizumab) – Expanded indication
- Roche Diagnostics – Recall of CoaguChek® XS PT Test Strips
- Sandoz – Recall of Losartan/Hydrochlorothiazide
- RxHighlights - October 2018 Edition
- Bryhali™ (halobetasol propionate) – New drug approval
- Primatene® Mist (epinephrine) – New over-the-counter drug (OTC) approval
- Yupelri™ (revefenacin) – New drug approval
- Keytruda® (pembrolizumab) – New indication
- Empliciti® (elotuzumab) – New indication
- RxOutlook - 4th Quarter 2018
- Finacea® (azelaic acid) – First-time generic
- Vusion® (miconazole/white petrolatum/zinc oxide) – First-time generic
- Adcetris® (brentuximab vedotin) – New indication
- Oralair® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue grass mixed pollens allergen extract) – Expanded indication
- Mylan – Recall of Valsartan-Containing Products
- Teva – Recall of Valsartan-Containing Products
- Aemcolo™ (rifamycin) – New drug approval
- Daurismo™ (glasdegib) – New drug approval
- Gamifant™ (emapalumab-lzsg) – New drug approval
- Temixys™ (lamivudine/tenofovir disoproxil fumarate) – New drug approval
- Vitrakvi® (larotrectinib) – New orphan drug approval
- Staxyn® (vardenafil) – First-time generic
- Zytiga® (abiraterone acetate) – First-time generic
- Gilenya® (fingolimod) – New warning
- Promacta® (eltrombopag) – Expanded indication
- Venclexta® (venetoclax) – New indication
- Mylan – Recall of Valsartan-Containing Products Update
- Methyldopa Tablets – Drug Shortage
- Dextenza® (dexamethasone ophthalmic insert) – New drug approval
- Firdapse® (amifampridine) – New orphan drug approval
- Truxima® (rituximab-abbs) – New biosimilar approval
- Xospata™ (gilteritinib) – New orphan drug approval
- Rapaflo® (silodosin) – First-time generic
- Idhifa® (enasidenib) – Safety communication
- Lemtrada® (alemtuzumab) – New warning
- Regranex® (becaplermin) – Removal of warning
- Seroquel®/Seroquel XR® (quetiapine) – New warning
- Astagraf XL® (tacrolimus) – Expanded indication
- Tecentriq® (atezolizumab) – Expanded indication
- Thyrolar® (liotrix) – Product discontinuation
- RxHighlights - November 2018 Edition
- Herzuma® (trastuzumab-pkrb) – New biosimilar approval
- Motegrity™ (prucalopride) – New drug approval
- Tolsura™ (itraconazole) – New drug approval
- Canasa® (mesalamine) – First-time generic
- Nplate® (romiplostim) – Expanded indication
- Oxtellar XR® (oxcarbazepine) – Expanded indication
- Viread® (tenofovir disoproxil fumarate) – Expanded indication
- Torrent – Recall of Losartan
- Envarsus XR® (tacrolimus) – New indication
- Keytruda® (pembrolizumab) – New indication
- Lynparza® (olaparib) – New indication
- Byvalson™ (nebivolol/valsartan) – Product discontinuation
- Moxatag® (amoxicillin) – Product discontinuation
- Asparlas™ (calaspargase pegol-mknl) – New orphan drug approval
- Elzonris™ (tagraxofusp-erzs) – New orphan drug approval
- Ezallor™ (rosuvastatin) – New drug approval
- Licart™ (diclofenac epolamine) – New drug approval
- Ultomiris™ (ravulizumab-cwvz) – New orphan drug approval
- Elidel® (pimecrolimus) – First-time generic
- Fluoroquinolone Antibiotics – Safety communication
- Aurobindo Pharma – Recall of Valsartan-Containing Products
- Elepsia™ XR (levetiracetam) – New drug approval
- Inbrija™ (levodopa) – New drug approval
- ProAir® Digihaler™ (albuterol sulfate) – New drug approval
- Vaxelis™ (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, Haemophilus b conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine) – New drug approval
- Ravicti® (glycerol phenylbutyrate) – Expanded indication
- Sprycel® (dasatinib) – Expanded indication
- Torrent – Recall of losartan
- Daklinza™ (daclatasvir) – Product discontinuation
- RxHighlights - December 2018 Edition
- Major – Recall of Losartan
- Cabometyx® (cabozantinib) – New indication
- Epclusa® (velpatasvir/sofosbuvir) and Harvoni® (ledipasvir/sofosbuvir) – First-time generics
- Prinston – Recall of Irbesartan-Containing Products
- Lupin – Recall of Ceftriaxone
- Torrent – Recall of losartan/hydrochlorothiazide
- ProAir® HFA (albuterol) – First-time generic
- Sabril® (vigabatrin) – First-time generic
- Ventolin® HFA (albuterol) – First-time generic
- Adagen® (pegademase bovine) – Product discontinuation
- Ontruzant® (trastuzumab-dttb) – New biosimilar approval
- Osphena® (ospemifene) – New indication
- Imbruvica® (ibrutinib) – Expanded indication
- Lartruvo® (olaratumab) – Safety communication
- Fareston® (toremifene) – First-time generic
- Tosymra™ (sumatriptan) – New drug approval
- Mylan – Recall of levoleucovorin
- Evekeo ODT™ (amphetamine sulfate) – New drug approval
- Gloperba® (colchicine) – New drug approval
- Advair Diskus® (fluticasone propionate/salmeterol) – First-time generic
- Rapamune® (sirolimus) – First-time generic
- Alimta® (pemetrexed) – Updated indication
- Sun Pharma – Recall of vecuronium
- RxHighlights - January 2019 Edition
- RxOutlook - 1st Quarter 2019
- Emadine® (emedastine difumarate) – Product discontinuation
- Cablivi® (caplacizumab-yhdp) – New orphan drug approval
- Jeuveau™ (prabotulinumtoxinA-xvfs) – New drug approval
- Zovirax® (acyclovir) – First-time generic
- Vfend® (voriconazole) – Expanded indication
- Egaten™ (triclabendazole) – New orphan drug approval
- Advair Diskus® (fluticasone propionate/salmeterol) – First-time generic launch update
- Ganirelix acetate – First-time generic
- Renagel® (sevelamer hydrochloride) – First-time generic
- Keytruda® (pembrolizumab) – Expanded indication
- Macleods – Recall of losartan/hydrochlorothiazide
- Grifols – Recall of Gamunex®-C (immune globulin [human])
- Esperoct® (antihemophilic factor [recombinant], glycopegylated-exei) – New drug approval
- Lotemax® SM (loteprednol etabonate) – New Drug Approval
- Vancomycin – New formulation approval
- Suboxone® (buprenorphine/naloxone) – First-time generic
- Uloric® (febuxostat) – Safety communication and updated indication
- Xeljanz™ (tofacitinib) – Safety update
- Lonsurf® (trifluridine/tipiracil) – New indication
- Aurobindo Pharma – Recall of valsartan-containing products
- Torrent – Recall of losartan-containing products
- Camber Pharmaceuticals – Recall of losartan
- Apotex – Recall of drospirenone and ethinyl estradiol tablets
- Adhansia XR™ (methylphenidate) – New drug approval
- Herceptin Hylecta™ (trastuzumab/hyaluronidase-oysk) – New formulation approval
- Amrix® (cyclobenzaprine) – First-time generic
- Apadaz® (benzhydrocodone/acetaminophen) – First-time generic (authorized generic)
- Humalog® (insulin lispro) – First-time generic (authorized generic)
- Ranexa® (ranolazine) – First-time generic
- Remodulin® (treprostinil) – First-time generic
- Soliqua® 100/33 (insulin glargine and lixisenatide) – Expanded indication
- Xultophy® 100/3.6 (insulin degludec and liraglutide injection) – Expanded indication
- American Health Packaging – Recall of valsartan
- RxHighlights - February 2019 Edition
- AvKARE – Recall of losartan-containing products
- Spravato™ (esketamine) – New drug approval
- Trazimera™ (trastuzumab-qyyp) – New biosimilar approval
- Flector® (diclofenac epolamine) – Expanded indication and first-time generic (authorized generic)
- Tekturna® (aliskiren) – First-time generic (authorized generic)
- Dupixent® (dupilumab) – Expanded indication
- Opdivo® (nivolumab) – Updated indication
- Tecentriq® (atezolizumab) – New indication
- Legacy Pharmaceutical Packaging – Recall of losartan
- Rocklatan™ (netarsudil and latanoprost) – New drug approval
- Mestinon® (pyridostigmine) – First-time generic
- Sensipar® (cinacalcet) – First-time generic
- Avycaz® (ceftazidime/avibactam) – Expanded indication
- Mayzent® (siponimod) – New drug approval
- Sunosi™ (solriamfetol) – New orphan drug approval
- Zulresso™ (brexanolone) – New drug approval
- Zykadia® (ceritinib) – New formulation approval
- Exjade® (deferasirox) – First-time generic
- Tecentriq® (atezolizumab) – New indication
- Preferred Pharmaceuticals – Recall of losartan
- Duaklir® Pressair® (aclidinium/formoterol fumarate) – New drug approval
- Jatenzo® (testosterone undecanoate) – New drug approval
- Mavenclad® (cladribine) – New drug approval
- Cimzia® (certolizumab pegol) – New indication
- Zelnorm™ (tegaserod) – Market re-introduction, updated indication
- Welchol® (colesevelam) – New formulation approval
- Asceniv™ (immune globulin intravenous, human – slra) – New drug approval
- Avaclyr™ (acyclovir) – New orphan formulation approval
- Ibrance® (palbociclib) – Expanded indications
- Proventil® HFA (albuterol) – First-time generic (authorized generic)
- RxHighlights - March 2019 Edition
- Balversa™ (erdafitinib) – New drug approval
- Dovato™ (dolutegravir and lamivudine) – New drug approval
- Evenity™ (romosozumab-aqqg) – New drug approval
- Letairis® (ambrisentan) – First-time generic
- Opioids – Safety update
- Keytruda® (pembrolizumab) – Expanded indication
- Torrent – Recall of losartan-containing products
- Alvogen – Recall of fentanyl transdermal system
- AvKARE – Recall of losartan
- Duzallo® (lesinurad/allopurinol), Zurampic® (lesinurad) – Product discontinuation
- Rebetol® (ribavirin) – Product discontinuation
- Corlanor® (ivabradine) – New orphan indication, new formulation approval
- Vesicare® (solifenacin) – First-time generic
- Keytruda® (pembrolizumab) – New indication
- Legacy Pharmaceutical Packaging – Recall of losartan
- B. Braun Medical – Recall of ceftazidime injection
- Major – Recall of losartan
- Teva – Recall of losartan
- Lartruvo® (olaratumab) – Product withdrawal
- Duobrii™ (halobetasol propionate and tazarotene) – New drug approval
- Eticovo™ (etanercept-ykro) – New biosimilar approval
- Skyrizi™ (risankizumab-rzaa) – New drug approval
- Kalydeco® (ivacaftor) – Expanded indication
- Praluent® (alirocumab) – New and expanded indications
- Sagent Pharmaceuticals – Recall of ketorolac tromethamine injection
- Vivimed – Recall of losartan
- Benlysta® (belimumab) – Expanded indication
- Kadcyla® (ado-trastuzumab emtansine) – New indication
- Mavyret™ (glecaprevir/pibrentasvir) – Expanded indication
- Qtern® (dapagliflozin/saxagliptin) – Expanded indication
- Tibsovo® (ivosidenib) – Expanded indication
- Dengvaxia® (dengue tetravalent vaccine, live) – New drug approval
- Qternmet® XR (dapagliflozin/saxagliptin/metformin) – New drug approval
- Vyndaqel® (tafamidis meglumine) and Vyndamax™ (tafamidis) – New orphan drug approvals
- Insomnia medications – Safety communication and updated labeling
- Novartis – Recall of Promacta® (eltrombopag)
- RxHighlights - April 2019 Edition
- Cyramza® (ramucirumab) – New indication and boxed warning removal
- Sorilux® (calcipotriene) – Expanded indication
- Ruzurgi™ (amifampridine) – New orphan drug approval
- Delzicol® (mesalamine) – First-time generic
- Tarceva® (erlotinib) – First-time generic
- Tracleer® (bosentan) – First-time generic
- Yosprala® (aspirin/omeprazole) – First-time generic (authorized generic)
- RxOutlook - 2nd Quarter 2019
- Bavencio® (avelumab) – New indication
- Eylea® (aflibercept) – Expanded indication
- Fragmin® (dalteparin) – New indication
- Gattex® (teduglutide) – Expanded indication
- Herzuma® (trastuzumab-pkrb) – New and expanded indications
- Venclexta® (venetoclax) – Expanded indication
- Xeomin® (incobotulinumtoxinA) – Expanded indication
- Nayzilam® (midazolam) – New orphan drug approval
- Cuprimine® (penicillamine) – First-time generic
- Lotemax® (loteprednol etabonate) – First-time generic
- Suprax® (cefixime) – First-time generic
- Jakafi® (ruxolitinib) – New orphan indication
- Livalo® (pitavastatin) – Expanded indication
- Lyrica® (pregabalin) – Expanded indication
- Revlimid® (lenalidomide) – New indications
- Truxima® (rituximab-abbs) – New and expanded indications
- Piqray® (alpelisib) – New drug approval
- Slynd® (drospirenone) – New drug approval
- Zolgensma® (onasemnogene abeparvovec-xioi) – New orphan drug approval
- Heritage Pharmaceuticals – Recall of amikacin and prochlorperazine injection products
- Vraylar® (cariprazine) – New indication
- Faslodex® (fulvestrant) – First-time generic
- Revatio® (sildenafil) – First-time generic
- Teva – Recall of losartan
- Emflaza® (deflazacort) – Expanded indication
- Emgality® (galcanezumab-gnlm) – New indication, new strength
- Keytruda® (pembrolizumab) – Expanded indications
- Zerbaxa® (ceftolozane/tazobactam) – New indication
- Nucala® (mepolizumab) – New formulation approval
- Polivy™ (polatuzumab vedotin-piiq) – New orphan drug approval
- Xospata® (gilteritinib) – New boxed warning
- Naftin® (naftifine) – First-time generic
- RxHighlights - May 2019 Edition
- Keytruda® (pembrolizumab) – New indication
- Victoza® (liraglutide) – Expanded indication
- Kanjinti™ (trastuzumab-anns) – New biosimilar approval
- B. Braun Medical – Recall of heparin
- Zytiga® (abiraterone acetate) – Safety updates
- Flurazepam – Drug shortage
- Fentora® (fentanyl) – First-time generic (authorized generic)
- Macleods – Recall of losartan-containing products
- Dextenza® (dexamethasone) – Expanded indication
- Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide) – Expanded indication
- Botox® (onabotulinumtoxinA) – Expanded indication
- Inflectra® (infliximab-dyyb) – Expanded indication
- Symdeko® (tezacaftor/ivacaftor and ivacaftor) – Expanded indication
- Myxredlin™ (insulin human in sodium chloride) – New drug approval
- Vyleesi™ (bremelanotide) – New drug approval
- Diclegis® (doxylamine succinate/pyridoxine) – First-time generic
- Medtronic – Recall of MiniMed™ Insulin Pumps
- Grifols -- Withdrawal of Gamunex-C® (immune globulin [human])
- Fresenius Kabi USA – Recall of fluorouracil
- Mvasi® (bevacizumab-awwb) – Updated indication and boxed warning removal
- Rescriptor® (delavirdine) – Product discontinuation
- Thiola® EC (tiopronin) – New formulation approval
- Zirabev™ (bevacizumab-bvzr) – New biosimilar approval
- Darzalex® (daratumumab) – Expanded indication
- Doptelet® (avatrombopag) – New indication
- Dupixent® (dupilumab) – New indication
- Renflexis® (infliximab-abda) – Expanded indication
- Soliris® (eculizumab) – New indication
- PharMEDium Services – Recall of hydromorphone
- Xembify® (immune globulin subcutaneous, human - klhw) – New drug approval
- Katerzia™ (amlodipine) – New formulation approval
- Xpovio™ (selinexor) – New orphan drug approval
- Hemabate® (carboprost tromethamine) – First-time generic
- Uloric® (febuxostat) – First-time generic
- RxHighlights - June 2019 Edition
- Firazyr® (icatibant) – First-time generic
- AirDuo ® Digihaler™ (fluticasone propionate/salmeterol) – New formulation approval
- Baxter – Recall of sodium chloride injection
- Otezla® (apremilast) – New orphan indication
- Bayer – Recall of Kogenate® FS antihemophilic factor (recombinant)
- Drizalma Sprinkle™ (duloxetine) – New formulation approval
- Kanjinti™ (trastuzumab-anns) – First-time biosimilar launch
- Mvasi™ (bevacizumab-awwb) – First-time biosimilar launch
- Recarbrio™ (imipenem/cilastatin/relebactam) – New drug approval
- Lyrica® (pregabalin) – First-time generic
- Jubilant Cadista – Recall of Drospirenone/Ethinyl Estradiol Tablets
- Accrufer® (ferric maltol) – New drug approval
- Baqsimi™ (glucagon) – New drug approval
- Hadlima™ (adalimumab-bwwd) – New biosimilar approval
- Ruxience™ (rituximab-pvvr) – New biosimilar approval
- Venclexta® (venetoclax) – New warning
- Xeljanz®, Xeljanz XR (tofacitinib) – New Boxed Warning
- Rozerem® (ramelteon) – First-time generic
- Lyrica® (pregabalin) – First-time generic
- Bayer – Update to Recall of Kogenate® FS antihemophilic factor (recombinant)
- Bionpharma – Recall of clobazam oral suspension
- Enstilar® (calcipotriene/betamethasone dipropionate) – Expanded indication
- Keytruda® (pembrolizumab) – New indication
- Taclonex® (calcipotriene/betamethasone dipropionate) – Expanded indication
- Nubeqa® (darolutamide) – New drug approval
- Turalio™ (pexidartinib) – New orphan drug approval
- RxHighlights - July 2019 Edition
- Clenpiq™ (sodium picosulfate/magnesium oxide/anhydrous citric acid) – Expanded indication
- Sirturo® (bedaquiline) – Expanded indication
- Pfizer – Recall of Relpax® (eletriptan)
- Asmanex HFA® (mometasone furoate) – Expanded indication, new strength
- Dulera® (mometasone furoate/formoterol fumarate dihydrate) – Expanded indication, new strength
- Human Papillomavirus Vaccination for Adults – Updated recommendations
- Inrebic® (fedratinib) – New orphan drug approval
- Pretomanid – New orphan drug approval
- Rinvoq™ (upadacitinib) – New drug approval
- Rozlytrek™ (entrectinib) – New orphan drug approval
- Wakix® (pitolisant) – New orphan drug approval
- Xenleta™ (lefamulin) – New drug approval
- Entacapone-Containing Products – Safety update
- Halog® (halcinonide) – First-time generic
- RxOutlook - 3rd Quarter 2019
- Myobloc® (rimabotulinumtoxinB) – New indication
- Taltz® (ixekizumab) – New indication
- Tybost ® (cobicistat) – Expanded indication
- Cloderm® (clocortolone) – First-time generic (authorized brand alternative)
- Dyrenium® (triamterene) – First-time generic
- Nourianz™ (istradefylline) – New drug approval
- Harvoni® (ledipasvir/sofosbuvir) – Expanded orphan indication, new formulation approval
- Riomet ER™ (metformin) – New formulation approval
- Sovaldi® (sofosbuvir) – Expanded orphan indication, new formulation approval
- Mavyret™ (glecaprevir/pibrentasvir), Zepatier® (elbasvir/grazoprevir), and Vosevi® (sofosbuvir/velpatasvir/voxilaprevir) – Safety update
- Capastat® Sulfate (capreomycin) – Drug shortage
- Noxafil® (posaconazole) – First-time generic
- Takeda – Recall of Natpara® (parathyroid hormone)
- RxHighlights - August 2019 Edition
- Orfadin® (nitisinone) – First-time generic
- NovoLog® (insulin aspart) and NovoLog Mix (insulin aspart protamine/insulin aspart) – (authorized brand alternatives)
- Emend® (fosaprepitant) – First-time generic
- Amicar® (aminocaproic acid) – First-time generic
- Plastikon Healthcare – Recall of Milk of Magnesia
- Gvoke™ (glucagon) – New drug approval
- Ofev® (nintedanib) – New orphan indication
- Ranitidine – Safety alert
- Ibrance® (palbociclib), Kisqali® (ribociclib), and Verzenio® (abemaciclib) – New Warning
- Abbott Nutrition – Recall of Calcilo XD®
- Ibsrela® (tenapanor) – New drug approval
- Nucala® (mepolizumab) – Expanded indication
- Lenvima ® (lenvatinib) and Keytruda ® (pembrolizumab) – New indication
- Aczone® (dapsone) – Expanded indication
- Teflaro® (ceftaroline fosamil) – Expanded indication
- Torrent – Recall of losartan-containing products
- Sandoz – Recall of ranitidine
- Rybelsus® (semaglutide) – New drug approval
- Ozobax™ (baclofen) – New drug approval
- Delstrigo® (doravirine/lamivudine/tenofovir disoproxil fumarate) – Expanded indication
- Erleada® (apalutamide) – New indication
- Pifeltro® (doravirine) – Expanded indication
- Apotex – Recall of ranitidine
- Crysvita® (burosumab-twza) – Expanded indication
- Jynneos™ (smallpox and monkeypox vaccine, live, nonreplicating) – New drug approval
- Darzalex® (daratumumab) – Expanded indication
- Dysport® (abobotulinumtoxinA) – Expanded indication
- Mavyret® (glecaprevir/pibrentasvir) – Label update
- Rituxan® (rituximab) – Expanded orphan indication
- Invokana® (canagliflozin) – New indication
- Descovy® (emtricitabine/tenofovir alafenamide) – New indication
- Entresto® (sacubitril/valsartan) – New indication
- Tybost® (cobicistat) – Expanded indication
- Aklief® (trifarotene) – New drug approval
- Bonsity™ (teriparatide) – New drug approval
- Fasenra® (benralizumab) – New formulation approval
- Hemady™ (dexamethasone) – New orphan drug approval
- Quzyttir™ (cetirizine) – New drug approval
- RxHighlights - September 2019 Edition
- Xarelto ® (rivaroxaban) – New indication
- Embeda® (morphine/naltrexone) – Drug discontinuation
- Reyvow ™ (lasmiditan) – New drug approval
- Scenesse® (afamelanotide) – New orphan drug approval
- Secuado® (asenapine) – New drug approval
- Farxiga ® (dapagliflozin) – New indication
- Nplate® (romiplostim) – Expanded indication
- Orenitram® (treprostinil) – Expanded indication
- Stelara® (ustekinumab) – New indication
- Ultomiris® (ravulizumab-cwvz) – New orphan indication
- Xofluza® (baloxavir marboxil) – Expanded indication
- Soolantra® (ivermectin) – First-time generic
- Biorphen® (phenylephrine) – New drug approval
- Amzeeq™ (minocycline) – New drug approval
- Trikafta™ (elexacaftor/tezacaftor/ivacaftor; ivacaftor) – New orphan drug approval
- Botox® (onabotulinumtoxinA) – Expanded indication
- Mylan – Recall of alprazolam
- Dr. Reddy’s – Recall of ranitidine
- Novitium and Lannett – Recall of ranitidine
- Baxdela® (delafloxacin) – New indication
- Cinvanti® (aprepitant) – Expanded indication
- Liletta® (levonorgestrel-releasing intrauterine system) – Expanded indication
- Zejula® (niraparib) – Expanded indication
- AvKare – Recall of ranitidine
- Fluzone® High-Dose Quadrivalent (influenza vaccine) – New formulation approval
- Otovel® (ciprofloxacin/fluocinolone) – First-time authorized brand alternative (ABA)
- Talicia® (omeprazole/amoxicillin/rifabutin) – New drug approval
- Vumerity™ (diroximel fumarate) – New drug approval
- Ziextenzo™ (pegfilgrastim-bmez) – New biosimilar approval
- Laboratory analysis of ranitidine and nizatidine products – Safety update
- Golden State Medical Supply and Aurobindo – Recall of ranitidine
- Grifols – Withdrawal of Gamunex-C® (immune globulin [human])
- American Health Packaging – Recall of ranitidine
- Absorica® LD™ (isotretinoin) – New formulation approval
- Ibrance® (palbociclib) – New formulation approval
- Reblozyl® (luspatercept-aamt) – New orphan drug approval
- Truxima® (rituximab-abbs) – First-time biosimilar launch
- Amneal – Recall of ranitidine
- RxHighlights - October 2019 Edition
- AvKare – Recall of ranitidine
- Precision Dose – Recall of ranitidine
- Abrilada™ (adalimumab-afzb) – New biosimilar approval
- Adakveo® (crizanlizumab) – New orphan drug approval
- Brukinsa™ (zanubrutinib) – New orphan drug approval
- Fetroja® (cefiderocol) – New drug approval
- Erwinaze® (asparginase Erwinia chrysanthemi) – Drug Shortage
- Sorilux ® (calcipotriene) – Expanded indication
- Baxter – Recall of sodium chloride irrigation
- American Health Packaging – Recall of ranitidine
- Calquence® (acalabrutinib) – New indication
- Givlaari® (givosiran) – New orphan drug approval
- Xcopri® (cenobamate) – New drug approval
- Jadenu® (deferasirox) – First-time generic
- Exservan® (riluzole) – New orphan drug approval
- Oxbryta™ (voxelotor) – New orphan drug approval
- RediTrex™ (methotrexate) – New drug approval
- Apriso® (mesalamine) – First-time generic
- Toujeo® (insulin glargine) – Expanded indication
- RxOutlook - 4th Quarter 2019
- RxHighlights - November 2019 Edition
- Flurazepam – Drug shortage
- Natpara® (parathyroid hormone) – Drug shortage
- Afinitor® (everolimus) – First-time generic
- Carafate® (sucralfate) – First-time generic
- Metformin – Safety update
- Laboratory analysis of ranitidine and nizatidine products – Safety update
- Tecentriq® (atezolizumab) – Expanded indication
- Avsola™ (infliximab-axxq) – New biosimilar approval
- Grifols – Withdrawal of Gamunex-C® (immune globulin [human])
- Roche – Recall of Accu-Chek® Aviva Plus
- Glenmark – Recall of ranitidine
- Vyondys 53™ (golodirsen) – New orphan drug approval
- NuvaRing® (etonogestrel/ethinyl estradiol) – First-time generic
- Vascepa® (icosapent ethyl) – New indication
- Xtandi® (enzalutamide) – New indication
- Lannett – Recall of levetiracetam oral solution
- Arazlo™ (tazarotene) – New drug approval
- Conjupri® (levamlodipine) – New drug approval
- Enhertu® (fam-trastuzumab deruxtecan-nxki) – New drug approval
- Ervebo® (Ebola Zaire Vaccine, Live) – New vaccine approval
- Padcev™ (enfortumab vedotin-ejfv) – New drug approval
- Gabapentin and pregabalin – Safety update
- Travatan-Z® (travoprost) – First-time generic
- Grifols – Withdrawal of Gamunex-C® (immune globulin [human])
- Dayvigo™ (lemborexant) – New drug approval
- Caplyta® (lumateperone) – New drug approval
- Ubrelvy™ (ubrogepant) – New drug approval
- Ezallor™ (rosuvastatin) – New drug approval
- Lynparza® (olaparib) – New indication
- Mycamine® (micafungin) – Expanded indication
- Aurobindo – Recall of mirtazapine
- Disulfiram – Drug shortage
- Phospholine Iodide® (echothiophate iodide) – Drug shortage
- Adzenys ER™ (amphetamine) – First-time authorized brand alternative
- Silenor® (doxepin) – First-time authorized brand alternative
- Symbicort® (budesonide/formoterol) – First-time authorized brand alternative
- Zohydro® ER (hydrocodone) – First-time authorized brand alternative
- Depen® (penicillamine) – First-time generic
- Mylan – Recall of nizatidine
- Appco Pharma – Recall of ranitidine
- RxHighlights - December 2019 Edition
- Taro Pharmaceuticals – Recall of lamotrigine
- Amneal – Recall of ranitidine
- Keytruda® (pembrolizumab) – Expanded indication
- Ayvakit™ (avapritinib) – New orphan drug approval
- Valtoco® (diazepam) – New orphan drug approval
- Ozempic® (semaglutide) – New indication; Rybelsus® (semaglutide) – Label update
- Humalog® Mix™ (insulin lispro protamine/insulin lispro) and Humalog (insulin lispro) Junior – First-time authorized brand alternatives
- Monoferric™ (ferric derisomaltose) – New drug approval
- Taclonex® (betamethasone dipropionate/calcipotriene) – First-time authorized brand alternative
- Belviq®, Belviq XR® (lorcaserin) – Safety update
- Methyldopa Tablets – Drug Shortage
- YF-Vax® – Drug shortage
- Tazverik™ (tazemetostat) – New orphan drug approval
- Tepezza™ (teprotumumab-trbw) – New orphan drug approval
- Dificid® (fidaxomicin) – Expanded orphan indication, New formulation
- Sabril® (vigabatrin) – Expanded indication
- Bynfezia® (octreotide acetate) – New drug approval
- Palforzia™ (peanut [Arachis hypogaea] allergen powder-dnfp) – New drug approval
- Trijardy™ XR (empagliflozin/linagliptin/metformin) – New drug approval
- Clozapine products – Safety update
- Metformin – Safety update
- Medtronic – Recall of MiniMed™ 600 Series Insulin Pumps
- Eisai – Withdrawal of Belviq®, Belviq XR (lorcaserin)
- RxHighlights - January 2020 Edition
- Moxeza® (moxifloxacin) – First-time generic
- Pataday® Once Daily Relief, Pataday Twice Daily Relief (olopatadine) – New over-the-counter approvals
- Pizensy™ (lactitol) – New drug approval
- Procysbi® (cysteamine bitartrate) – New formulation approval
- Voltaren® Arthritis Pain (diclofenac) – New over-the-counter approval
- Twirla® (levonorgestrel/ethinyl estradiol) – New drug approval
- Audenz™ (Influenza A [H5N1] Monovalent Vaccine, Adjuvanted) – New drug approval
- Taro Pharmaceuticals – Recall of phenytoin
- RxOutlook - 1st Quarter 2020
- Anjeso™ (meloxicam) – New drug approval
- Nexletol™ (bempedoic acid) – New drug approval
- Vyepti™ (eptinezumab-jjmr) – New drug approval
- Trulicity® (dulaglutide) – New indication
- American Health Packaging – Recall of ranitidine
- ArmonAir® Digihaler™ (fluticasone propionate) – New formulation approval
- Barhemsys® (amisulpride) – New drug approval
- Nexlizet™ (bempedoic acid/ezetimibe) – New drug approval
- Nurtec™ ODT (rimegepant) – New drug approval
- Sarclisa® (isatuximab-irfc) – New orphan drug approval
- ProAir® HFA (albuterol) – First-time generic
- Vimovo® (naproxen/esomeprazole magnesium) – First-time generic
- Nerlynx® (neratinib) – New indication
- RxHighlights - February 2020 Edition
- Ofev® (nintedanib) – Expanded indication
- Symtuza® (darunavir/cobicistat/emtricitabine/tenofovir) – Expanded indication
- Durysta™ (bimatoprost implant) – New drug approval
- Isturisa® (osilodrostat) – New orphan drug approval
- Montelukast – Safety update
- Dymista® (azelastine/fluticasone propionate) – First-time generic
- Opdivo® (nivolumab) – Expanded indication
- Zortress® (everolimus) – First-time generic
- Novartis – Recall of Sandimmune® (cyclosporine) and Neoral® (cyclosporine)
- Albuterol inhalers – Drug shortage
- Eprosartan – Product discontinuation
- Sodium glucose co-transporter-2 (SGLT2) inhibitors – Safety update
- Daraprim® (pyrimethamine) – First-time generic
- Epclusa® (sofosbuvir/velpatasvir) – Expanded indication, New strength
- Imfinzi® (durvalumab) – New indication
- Triferic AVNU® (ferric pyrophosphate citrate) – New formulation approval
- Zeposia® (ozanimod) – New drug approval
- Taltz® (ixekizumab) – Expanded indication
- Nexium® (esomeprazole) – First-time generic
- FDA – Withdrawal of ranitidine
- Sevenfact® (coagulation factor VIIa [recombinant]-jncw) – New drug approval
- Reblozyl® (luspatercept-aamt) – New indication
- RxHighlights - March 2020 Edition
- Braftovi® (encorafenib) – New indication
- Epidiolex® (cannabidiol) – DEA Descheduling
- Koselugo® (selumetinib) – New orphan drug approval
- Amneal – Recall of nizatidine
- Avet Pharmaceuticals – Recall of tetracycline
- B. Braun Medical – Recall of ceftazidime
- BD – Recall of PosiFlush™ SF Saline Flush Syringe
- Fresenius Kabi – Recall of ketorolac injection
- Nalbuphine Injection – Drug Shortage
- Jelmyto™ (mitomycin) – New orphan drug approval
- Pemazyre™ (pemigatinib) – New orphan drug approval
- Tukysa™ (tucatinib) – New orphan drug approval
- Trividia Health – Recall of True Metrix® Air Blood Glucose Meter
- MenQuadfi™ (meningococcal [Groups A, C, Y, W] conjugate vaccine) – New drug approval
- Ongentys ® (opicapone) – New drug approval
- Trodelvy™ (sacituzumab govitecan-hziy) – New drug approval
- Mycamine® (micafungin) – First-time generic
- Cymbalta® (duloxetine) – Expanded indication
- Bafiertam™ (monomethyl fumarate) – New drug approval
- Zejula® (niraparib) – Expanded indication
- Darzalex Faspro™ (daratumumab and hyaluronidase-fihj) – New formulation approval
- Fensolvi® (leuprolide acetate) – New drug approval
- Milprosa™ (progesterone) – New drug approval
- Singulair® (montelukast sodium) – New Boxed Warning
- ICU Medical – Recall of Lactated Ringer’s injection
- RxHighlights - April 2020 Edition
- Aptensio XR™ (methylphenidate) – First-time authorized brand alternative
- Elyxyb™ (celecoxib) – New formulation approval
- Retevmo™ (selpercatinib) – New orphan drug approval
- Tabrecta™ (capmatinib) – New orphan drug approval
- Farxiga® (dapagliflozin) – New indication
- Lynparza® (olaparib) – New indication
- RxOutlook - 2nd Quarter 2020
- Pomalyst® (pomalidomide) – New orphan indication
- Rubraca® (rucaparib) – New indication
- Qinlock™ (ripretinib) – New orphan drug approval
- Acella Pharmaceuticals – Recall of NP Thyroid® (thyroid tablets)
- Lynparza® (olaparib) – New indication
- Tecentriq® (atezolizumab) – Expanded indication
- Alunbrig® (brigatinib) – Expanded indication
- Opdivo® (nivolumab), Yervoy® (ipilimumab) – New indication
- Ferriprox® (deferiprone) – New formulation approval
- Impeklo™ (clobetasol propionate) – New drug approval
- Kynmobi™ (apomorphine) – New drug approval
- Phexxi™ (lactic acid/citric acid/potassium bitartrate) – New drug approval
- Samsca® (tolvaptan) – First-time generic
- Metformin Extended-Release Products – Safety update
- Cyramza® (ramucirumab) – Expanded indication
- Dupixent® (dupilumab) – Expanded indication
- Teva – Recall of metformin extended-release (ER)
- Sirturo® (bedaquiline) – Expanded indication
- Brilinta® (ticagrelor) – New indication
- Opdivo® (nivolumab), Yervoy® (ipilimumab) – New indication
- Taltz® (ixekizumab) – New indication
- Tecentriq® (atezolizumab), Avastin® (bevacizumab) – New indication
- Artesunate – New orphan drug approval
- Oriahnn™ (elagolix/estradiol/norethindrone acetate; elagolix) – New drug approval
- VESIcare LS™ (solifenacin succinate) – New drug approval
- Zilxi™ (minocycline) – New drug approval
- Amneal – Recall of metformin extended-release (ER)
- Epinephrine auto-injector – Safety communication
- Apotex, AvKare, and Marksans – Recalls of metformin extended-release
- RxHighlights - May 2020 Edition
- Recarbrio® (imipenem/cilastatin/relebactam) – New indication
- Lupin – Recall of metformin extended-release
- Gardasil® 9 (human papillomavirus 9-valent vaccine, recombinant) – Expanded indication
- Opdivo® (nivolumab) – New indication
- Nyvepria™ (pegfilgrastim-apgf) – New biosimilar approval
- Semglee® (insulin glargine) – New drug approval
- Tivicay® (dolutegravir), Tivicay PD (dolutegravir) – Expanded indication, New formulation approval
- Uplizna™ (inebilizumab-cdon) – New orphan drug approval
- Zepzelca™ (lurbinectedin) – New orphan drug approval
- Amoxapine – Drug Shortage
- Lyumjev™ (insulin lispro-aabc) – New drug approval
- Cosentyx® (secukinumab) – New indication
- Crysvita® (burosumab-twza) – New indication
- Ilaris® (canakinumab) – Expanded indication
- Keytruda® (pembrolizumab) – New indication
- Mylotarg™ (gemtuzumab ozogamicin) – Expanded indication
- Tazverik™ (tazemetostat) – New indications
- Xpovio® (selinexor) – New indication
- Gimoti™ (metoclopramide) – New drug approval
- Desonate® (desonide) – First-time generic
- Keytruda® (pembrolizumab) – New indication
- Keytruda ® (pembrolizumab) – New indication
- Sivextro® (tedizolid) – Expanded indication
- Fintepla ® (fenfluramine) – New orphan drug approval
- Mycapssa ® (octreotide) – New orphan drug approval
- Phesgo ™ (pertuzumab/trastuzumab/hyaluronidase-zzxf) – New drug approval
- Major – Recall of metformin extended-release (ER)
- Granules Pharmaceuticals – Recall of metformin extended-release (ER)
- Mylan – Recall of daptomycin injection
- Byfavo ™ (remimazolam) – New drug approval
- Dojolvi ™ (triheptanoin) – New orphan drug approval
- Hulio® (adalimumab-fkjp) – New biosimilar approval
- Rukobia ™ (fostemsavir) – New drug approval
- Qwo ™ (collagenase clostridium histolyticum-aaes) – New drug approval
- Bavencio ® (avelumab) – Expanded indication
- Lialda ® (mesalamine) – Expanded indication
- Lupin – Recall of metformin extended-release (ER)
- RxHighlights - June 2020 Edition
- Upneeq ™ (oxymetazoline) – New drug approval
- Inqovi ® (decitabine/cedazuridine) – New orphan drug approval
- Botox ® (onabotulinumtoxinA) – Expanded indication
- Dysport ® (abobotulinumtoxinA) – Expanded indication
- B. Braun Medical – Withdrawal of heparin
- Fresenius Kabi – Recall of fosaprepitant
- Tremfya ® (guselkumab) – New indication
- Nizatidine – Drug Shortage
- Breztri Aerosphere™ (budesonide/glycopyrrolate/formoterol) – New drug approval
- Tecartus™ (brexucabtagene autoleucel) – New orphan drug approval
- Wynzora ® (calcipotriene/betamethasone dipropionate) – New drug approval
- Xeglyze ™ (abametapir) – New drug approval
- Xywav ™ (calcium, magnesium, potassium, and sodium oxybates) – New orphan drug approval
- Naloxone – Safety Update
- Qutenza ® (capsaicin) – Expanded indication
- Vectical ® (calcitriol) – Expanded indication
- Monjuvi® (tafasitamab-cxix) – New drug approval
- Demser® (metyrosine) – First-time generic
- Epidiolex® (cannabidiol) – New and expanded indications
- Evotaz ® (atazanavir/cobicistat) – Expanded indication
- Prezcobix® (darunavir/cobicistat) – Expanded indication
- Spravato® (esketamine) – New indication
- Stelara® (ustekinumab) – Expanded indication
- Tecentriq® (atezolizumab) – New indication approval
- Ferring US – Recall of desmopressin nasal spray products
- RxHighlights - July 2020 Edition
- Sprix® (ketorolac) – First-time authorized brand alternative
- Dovato ® (dolutegravir/lamivudine) – Expanded indication
- Suprep ® Bowel Prep Kit (sodium sulfate/potassium sulfate/magnesium sulfate) – Expanded indication and new strength
- Blenrep ® (belantamab mafodotin-blmf) – New orphan drug approval
- Evrysdi™ (risdiplam) – New orphan drug approval
- Lampit ® (nifurtimox) – New orphan drug approval
- Olinvyk ™ (oliceridine) – New drug approval
- Xtandi ® (enzalutamide) – New formulation approval
- Ciprodex® (ciprofloxacin/dexamethasone) – First-time generic
- Jadenu® Sprinkle (deferasirox) – First-time generic
- Lacrisert® (hydroxypropyl cellulose) – Drug Shortage
- RxOutlook - 3rd Quarter 2020
- Enspryng™ (satralizumab-mwge) – New orphan drug approval
- Bayshore Pharmaceuticals – Recall of metformin extended-release (ER)
- Onureg® (azacitidine oral tablets) – New orphan drug approval
- Qdolo® (tramadol) – New drug approval
- Xaracoll® (bupivacaine) – New drug approval
- Emtriva® (emtricitabine) – First-time generic
- Symfi®/Symfi Lo® (efavirenz/lamivudine/tenofovir disoproxil fumarate) – First-time generics
- Ultravate® (halobetasol propionate) – Expanded indication
- RxHighlights - August 2020 Edition
- Gavreto® (pralsetinib) – New orphan drug approval
- Trelegy Ellipta® (fluticasone furoate/umeclidinium/vilanterol) – New indication
- Acella Pharmaceuticals – Recall of NP Thyroid® (thyroid)
- Bethkis® (tobramcyin) – First-time generic and authorized brand alternative
- Ferriprox® (deferiprone) – First-time generic
- Sun Pharmaceuticals – Recall of Riomet ER™ (metformin)
- Xeljanz ® (tofacitinib) – New indication, new formulation
- Benzodiazepine Drug Class – Safety update
- Eraxis® (anidulafungin) – Expanded indication
- Fetroja® (cefiderocol) – New indication
- Kalydeco® (ivacaftor) – Expanded indication
- Nucala® (mepolizumab) – New indication
- Marksans Pharma – Recall metformin extended-release (ER)
- Alkindi® Sprinkle (hydrocortisone) – New orphan drug approval
- Zorvolex® (diclofenac) – First-time authorized brand alternative
- Kuvan® (sapropterin) – First-time generic
- Truvada® (emtricitabine/tenofovir disoproxil fumarate) and Atripla® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) – First-time generics
- Tykerb® (lapatinib) – First-time generic
- Haegarda® (C1 esterase inhibitor [human]) – Expanded indication
- Simponi Aria® (golimumab) – New indication, expanded indication
- Opdivo® (nivolumab), Yervoy® (ipilimumab) – New indication
- RxHighlights - September 2020 Edition
- Monurol® (fosfomycin) – First-time generic
- Inmazeb™ (atoltivimab/maftivimab/odesivimab-ebgn) – New orphan drug approval
- Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) – Safety update
- Keytruda® (pembrolizumab) – Expanded indication
- Wakix® (pitolisant) – Expanded indication
- Sunstar Americas – Recall of Paroex® (chlorhexidine gluconate)
- Veklury® (remdesivir) – New drug approval
- Nostrum Laboratories – Recall of metformin extended-release (ER)
- Bydureon® (exenatide) Pen – Product discontinuation
- Picato® (ingenol mebutate) – Product discontinuation
- Bronchitol® (mannitol) – New drug approval
- Eysuvis™ (loteprednol etabonate) – New drug approval
- Sklice® (ivermectin) – New over-the-counter approval
- Kerydin® (tavaborole) – First-time generic
- Tirosint® (levothyroxine) – First-time authorized brand alternative
- RxHighlights - October 2020 Edition
- Lohxa – Recall of chlorhexidine gluconate
- Sesquient™ (fosphenytoin sodium) – New drug approval
- Vascepa® (icosapent ethyl) – First-time generic
- Banzel® (rufinamide) – First-time generic
- Totect® (dexrazoxane) – New indication
- Selzentry® (maraviroc) – Expanded indication
- Brilinta® (ticagrelor) – New indication
- Sutab® (sodium sulfate/magnesium sulfate/potassium chloride) – New drug approval
- Taytulla® (ethinyl estradiol/norethindrone/ferrous fumarate) – First-time generic
- Keytruda® (pembrolizumab) – New indication
- Vimpat® (lacosamide) – New indication
- RxOutlook - 4th Quarter 2020
- Danyelza® (naxitamab-gqgk) – New orphan drug approval
- Forteo® (teriparatide) – Updated drug label
- Alinia® (nitazoxanide) – First-time generic
- Entereg® (alvimopan) – First-time generic
- Imcivree™ (setmelanotide) – New orphan drug approval
- Olumiant® (baricitinib) – Emergency use authorization approval
- Oxlumo® (lumasiran) – New orphan drug approval
- Xofluza® (baloxavir marboxil) – New indication, new formulation approval
- Zokinvy™ (lonafarnib) – New orphan drug approval
- MPM Medical – Recall of Regenecare® HA Hydrogel (lidocaine)
- AvKare – Recall of sildenafil and trazodone
- Hetlioz®, Hetlioz LQ™ (tasimelteon) – New orphan indication, new formulation approval
- Orladeyo™ (berotralstat) – New orphan drug approval
- Gavreto™ (pralsetinib) – New orphan indications
- Saxenda® (liraglutide) – Expanded indication
- Xolair® (omalizumab) – New indication
- Torrent Pharmaceuticals Limited – Recall of anagrelide
- RxHighlights - November 2020 Edition
- Klisyri ® (tirbanibulin) – New drug approval
- Thyquidity™ (levothyroxine sodium) – New drug approval
- Saphris® (asenapine) – First-time generic and authorized brand alternative
- Ofirmev® (acetaminophen) – First-time generic
- Margenza™ (margetuximab-cmkb) – New drug approval
- Orgovyx™ (relugolix) – New drug approval
- Riabni™ (rituximab-arrx) – New biosimilar approval
- Benlysta® (belimumab) – New indication
- Tagrisso® (osimertinib) – New indication
- Xpovio® (selinexor) – Expanded indication
- Fresenius Kabi – Recall of ketorolac injection
- Fresenius Kabi – Recall of ketorolac injection
- Kineret® (anakinra) – New indication
- Arcalyst® (rilonacept) – New indication
- Iclusig® (ponatinib) – Expanded indication
- Trikafta® (elexacaftor/tezacaftor/ivacaftor; ivacaftor), Symdeko® (tezacaftor/ivacaftor; ivacaftor), Kalydeco® (ivacaftor) – Expanded indication, label updates
- Xeomin® (incobotulinumtoxinA) – Expanded indication
- Gemtesa® (vibegron) – New drug approval
- Vivlodex® (meloxicam) – First-time generic
- Sunstar Americas – Recall of Paroex® (chlorhexidine gluconate)
- RxHighlights - December 2020 Edition
- Precision Dose – Recall of Paroex® (chlorhexidine gluconate)
- Nostrum Laboratories – Recall of metformin extended-release (ER)
- B. Braun Medical – Withdrawal of heparin
- Glucagon® Emergency Kit for Low Blood Sugar (glucagon) – First-time generic
- Amitiza® (lubiprostone) – First-time authorized brand alternative
- Opdivo® (nivolumab) – Indication withdrawal
- Nostrum Laboratories – Recall of metformin extended-release (ER)
- Xalkori® (crizotinib) – New indication
- Darzalex Faspro® (daratumumab/hyaluronidase-fihj) – New indication, expanded indication
- Opdivo® (nivolumab), Cabometyx® (cabozantinib) – Expanded indication
- Zomig® (zolmitriptan) – First-time authorized brand alternative
- Enhertu® (fam-trastuzumab deruxtecan-nxki) – New indication
- Cabenuva (cabotegravir, rilpivirine), Vocabria (cabotegravir) – New drug approvals
- Verquvo™ (vericiguat) – New drug approval
- Lupkynis™ (voclosporin) – New drug approval
- BRP – Recall of spironolactone
- Meitheal Pharmaceuticals – Recall of cisatracurium injection
- Gocovri® (amantadine) – New indication
- Nplate® (romiplostim) – New indication
- Rapivab® (peramivir) – Expanded indication
- Apotmex – Recall of enoxaparin injection
- RxHighlights - January 2021 Edition
- Breyanzi® (lisocabtagene maraleucel) – New orphan drug approval
- Tepmetko® (tepotinib) – New drug approval
- Ukoniq™ (umbralisib) – New orphan drug approval
- Xeljanz®, Xeljanz XR (tofacitinib) – Safety update
- Botox® (onabotulinumtoxinA) – New indication
- Entresto® (sacubitril/valsartan) – Expanded indication
- Libtayo® (cemiplimab-rwlc) – New indication
- Cosela ™ (trilaciclib) – New drug approval
- Evkeeza™ (evinacumab) – New orphan drug approval
- Foscavir® (foscarnet) – First-time generic
- Lotemax® (loteprednol) – First-time generic
- RxOutlook - 1st Quarter 2021
- Imfinzi® (durvalumab) – Indication withdrawal
- Libtayo® (cemiplimab-rwlc) – New indication
- Panzyga® (immune globulin intravenous, human - ifas) – New indication
- Northera® (droxidopa) – First-time generic
- Amondys 45™ (casimersen) – New orphan drug approval
- Nulibry™ (fosdenopterin) – New orphan drug approval
- Pepaxto® (melphalan flufenamide) – New orphan drug approval
- Xulane® (ethinyl estradiol/norelgestromin) – First-time generic
- Grifols – Withdrawal of Gamunex-C® (immune globulin [human])
- RxHighlights - February 2021 Edition
- Actemra® (tocilizumab) – New indication
- Keytruda® (pembrolizumab) – Indication withdrawal
- Lorbrena® (lorlatinib) – Expanded indication
- Tecentriq® (atezolizumab) – Indication withdrawal
- Yescarta® (axicabtagene ciloleucel) – New indication
- Azstarys™ (serdexmethylphenidate/dexmethylphenidate) – New drug approval
- Drug Shortage – bupivacaine/epinephrine injection
- Drug Shortage – Ethyol® (amifostine)
- Hysingla™ ER (hydrocodone bitartrate) – First-time generic
- Azopt® (brinzolamide) – First-time generic
- Fotivda® (tivozanib) – New drug approval
- Kimyrsa™ (oritavancin) – New drug approval
- Fabrazyme® (agalsidase beta) – Expanded indication
- Sagent – Recall of phenylephrine injection
- Bryant Ranch Repack – Recall of spironolactone
- Keytruda® (pembrolizumab) – Expanded indication
- Arcalyst® (rilonacept) – New orphan indication
- Ponvory™ (ponesimod) – New drug approval
- Zegalogue® (dasiglucagon) – New drug approval
- Grifols – Withdrawal of Gamunex-C® (immune globulin [human])
- Alembic – Recall of telmisartan
- Zydus – Recall of acyclovir injection
- Abecma™ (idecabtagene vicleucel) – New orphan drug approval
- Myrbetriq ®, Myrbetriq® Granules (mirabegron extended-release) – New indication, new formulation approval
- Roszet (rosuvastatin/ezetimibe) – New drug approval
- Exparel® (bupivacaine) – Expanded indication
- Apotex – Recall of guanfacine
- RxHighlights - March 2021 Edition
- Praluent® (alirocumab) – New orphan indication
- Sarclisa® (isatuximab-irfc) – New indication
- Tyvaso ® (treprostinil) – New indication
- Vyxeos® (daunorubicin and cytarabine) – Expanded indication
- Qelbree™ (viloxazine) – New drug approval
- Trodelvy ® (sacituzumab govitecan-hziy) – Expanded indication
- Long-Term Drug Shortage – Cystaran® (cysteamine)
- Trodelvy® (sacitzumab govitecan-hziy) – New indication
- Xolair® (omalizumab) – Updated dosing
- Opdivo® (nivolumab) – New indication
- Evekeo ODT™ (amphetamine sulfate) – Expanded indication, new strength
- Nextstellis® (drospirenone/estetrol) – New drug approval
- bamlanivimab – Emergency use authorization revoked
- J&J COVID-19 Vaccine - Use Paused Due to Possible Safety Concern
- Lyrica® CR (pregabalin) – First-time generic
- Ragwitek® (short ragweed pollen allergen extract) – Expanded indication
- Diovan® (valsartan) – Expanded indication
- Zynlonta™ (loncastuximab tesirine-lpyl) – New drug approval
- Jemperli™ (dostarlimab) – New drug approval
- BD – Recall of ChloraPrep™ Hi-Lite Orange™ (chlorhexidine gluconate/isopropyl alcohol)
- J&J COVID-19 Vaccine – ACIP Recommends Continued Use
- Long-Term Drug Shortage – Zerbaxa® (ceftolozane/tazobactam)
- Grifols – Withdrawal of Gamunex-C® (immune globulin [human])
- Acella Pharmaceuticals – Recall of NP Thyroid® (thyroid)
- Natroba® (spinosad) – New indication
- Ferriprox® (deferiprone) – New indication, expanded indication
- Farxiga® (dapagliflozin) – New indication
- Kloxxado™ (naloxone) – New drug approval
- Absorica® (isotretinoin) – First-time generic
- RxHighlights - April 2021 Edition
- Keytruda® (pembrolizumab) – Expanded indication
- Pfizer COVID-19 Vaccine – Expanded use in adolescents 12 – 15 years old
- RxOutlook - 2nd Quarter 2021
- Empaveli™ (pegcetacoplan) – New orphan drug approval
- Thiola® (tiopronin) – First-time generic
- Rybrevant™ (amivantamab-vmjw) – New drug approval
- Miacalcin® (calcitonin salmon) – First-time generic
- Opdivo® (nivolumab) – Expanded indication
- Yervoy® (ipilimumab) – Expanded indication
- Ocaliva ® (obeticholic acid) – Safety update
- Lumakras ™ (sotorasib) – New orphan drug approval
- Lybalvi™ (olanzapine/samidorphan) – New drug approval
- Myfembree® (relugolix/estradiol/norethindrone acetate) – New drug approval
- Truseltiq™ (infigratinib) – New drug approval
- Brovana® (arformoterol) – First-time authorized brand alternative
- Cosentyx® (secukinumab) – Expanded indication
- Nurtec® ODT (rimegepant) – New indication
- Sotrovimab – Emergency use authorization approval
- Zeposia® (ozanimod) – New indication
- Zipsor ® (diclofenac potassium) – Expanded indication
- Aduhelm™ (aducanumab) – New drug approval
- Brexafemme® (ibrexafungerp) – New drug approval
- Camcevi® (leuprolide) – New drug approval
- Noxafil® PowderMix, Noxafil® (posaconazole) – New formulation approval, expanded indication
- Ryplazim® (plasminogen, human-tvmh) – New orphan drug approval
- Wegovy™ (semaglutide) – New drug approval
- Bepreve® (bepotastine) – First-time generic
- Ultomiris® (ravulizumab-cwvz) – Expanded indication
- RxHighlights - May 2021 Edition
- Trikafta® (elexacaftor/tezacaftor/ivacaftor; ivacaftor) – Expanded indication, new strength
- Epclusa® (sofosbuvir/velpatasvir) – Expanded indication, new formulation approval
- Mavyret® (glecaprevir/pibrentasvir) – Expanded indication, new formulation approval
- Prevnar 20™ (pneumococcal 20-valent conjugate vaccine) – New drug approval
- Banzel® (rufinamide) – First-time generic
- Kaletra® (lopinavir/ritonavir) – First-time generic
- UltiMed – Withdrawal of UltiCare® pen needles
- Ayvakit™ (avapritinib) – New indication
- Astepro® Allergy and Children’s Astepro Allergy (azelastine) – New partial over-the-counter approval
- Pradaxa® (dabigatran etexilate) – New formulation approval, new indication
- Soaanz® (torsemide) – New drug approval
- StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat) – New orphan drug approval
- Intelence® (etravirine) – First-time generic
- Grifols – Withdrawal of Gamunex-C® (immune globulin [human])
- Toviaz® (fesoterodine fumarate) – New indication
- Chantix® (varenicline) – Pause on Distribution
- Actemra® (tocilizumab)– Emergency use authorization approval
- Verkazia® (cyclosporine) – New orphan drug approval
- Perforomist® (formoterol fumarate) – First-time generic
- Pfizer – Recall of Chantix® (varenicline) to warehouse level
- Rylaze™ (asparaginase erwinia chrysanthemi [recombinant]¬rywn) – New orphan drug approval
- Keytruda® (pembrolizumab) – Indication withdrawal
- Solosec® (secnidazole) – New indication
- RxHighlights - June 2021 Edition
- Aduhelm™ (aducanumab-avwa) – Updated labeling
- Darzalex Faspro® (daratumumab and hyaluronidase-fihj) – Expanded indication
- Keytruda® (pembrolizumab) – Expanded indication
- Padcev® (enfortumab vedotin-ejfv) – Expanded indication
- Kerendia™ (finerenone) – New drug approval
- Pfizer – Recall of Chantix® (varenicline)
- Vaxneuvance™ (pneumococcal 15-valent conjugate) – New vaccine approval
- Rezurock™ (belumosudil) – New orphan drug approval
- Prograf ® (tacrolimus) – Expanded indication
- Octagam 10%® (immune globulin intravenous [human]) – New indication
- Feraheme® (ferumoxytol) – First-time generic
- Twyneo® (tretinoin/benzoyl peroxide) – New drug approval
- Fexinidazole – New orphan drug approval
- Bylvay™ (odevixibat) – New orphan drug approval
- Statins – Removal of contraindication
- Shingrix (Zoster vaccine recombinant, adjuvanted) – Expanded indication
- Opdivo® (nivolumab) – Indication withdrawal
- Drizalma Sprinkle™ (duloxetine delayed-release) – New indication
- Dalvance® (dalbavancin) – Expanded indication
- Bydureon BCise® (exenatide extended-release) – Expanded indication
- Pepaxto® (melphalan flufenamide) – Safety update
- Semglee® (insulin glargine-yfgn) – First new interchangeable biosimilar approval
- Saphnelo® (anifrolumab-fnia) – New drug approval
- Uptravi® (selexipag) injection – New formulation approval
- Olumiant® (baricitinib) – Emergency use authorization expansion
- Nucala® (mepolizumab) – New indication
- Keytruda® (pembrolizumab) – Expanded indication
- REGEN-COV™ (casirivimab/imdevimab) – Emergency use authorization expansion
- RxHighlights - July 2021 Edition
- Grifols – Withdrawal of Gamunex-C® (immune globulin [human])
- KVK Tech – Recall of atovaquone oral suspension
- Duexis® (ibuprofen/famotidine) – First-time generic
- Nexviazyme® (avalglucosidase alfa-ngpt) – New orphan drug approval
- Istodax® (romidepsin) – Indication withdrawal
- Pfizer – Expansion of recall of Chantix® (varenicline)
- Ticovac™ (tick-borne encephalitis vaccine) – New vaccine approval
- Welireg™ (belzutifan) – New drug approval
- Durezol® (difluprednate) – First-time generic
- Keytruda® (pembrolizumab), Lenvima® (lenvatinib) – Expanded indication
- Mirena® (levonorgestrel-releasing intrauterine system) – Expanded indication
- Pfizer-BioNTech and Moderna COVID-19 vaccines – Emergency use authorization updated for additional dose for certain immunocompromised individuals
- Xywav® (calcium/magnesium/potassium/sodium oxybates) – New indication
- Comirnaty® (COVID-19 vaccine, mRNA) – New vaccine approval
- Korsuva™ (difelikefalin) – New drug approval
- Epaned® (enalapril) – First-time generic
- COVID-19 Vaccines – HHS Statement on Booster Doses
- Jardiance® (empagliflozin) – New indication
- Jemperli (dostarlimab-gxly) – New indication
- Lexette® (halobetasol propionate) – Expanded indication
- Opdivo® (nivolumab) – Expanded indication
- Xarelto® (rivaroxaban) – Expanded indication
- Evomela® (melphalan) – Indication withdrawal
- Sutent® (sunitinib) – First-time generic
- RxOutlook - 3rd Quarter 2021
- Teligent Pharma – Recall of lidocaine topical solution
- Tecentriq® (atezolizumab) – Indication withdrawal
- Briviact® (brivaracetam) – Expanded indication
- Tibsovo® (ivosidenib) – New indication
- Skytrofa® (lonapegsomatropin-tcgd) – New orphan drug approval
- Keytruda® (pembrolizumab) – Updated indication
- Brukinsa® (zanubrutinib) – New orphan indication
- Invega Hafyera™ (paliperidone palmitate) – New drug approval
- Trudhesa™ (dihydroergotamine mesylate) – New drug approval
- Meitheal – Recall of glycopyrrolate injection
- Oral JAK Inhibitors (Xeljanz®/XR, Olumiant®, Rinvoq®) – Safety update
- ICU Medical – Recall of Aminosyn® II injection
- Azurity – Recall of Firvanq® (vancomycin for oral solution)
- RxHighlights - August 2021 Edition
- Jacobus – Recall of Ruzurgi® (amifampridine)
- Paxil® (paroxetine hydrochloride) – First-time generic
- Pfizer –Recall of Chantix® (varenicline)
- COVID-19 Vaccines – FDA Advisors Discuss Vaccine Boosters
- COVID-19 Vaccines – Pfizer Vaccine Use in Children
- Bystolic® (nebivolol) – First-time generic
- Cabometyx® (cabozantinib) – New indication
- Byooviz™ (ranibizumab-nuna) – New biosimilar approval
- Brukinsa® (zanubrutinib) – New indication
- bamlanivimab/etesevimab – Emergency use authorization expansion
- Exkivity™ (mobocertinib) – New orphan drug approval
- Tivdak™ (tisotumab vedotin-tftv) – New drug approval
- COVID-19 Vaccines – CDC’s ACIP Discusses Vaccine Boosters (Day 1)
- COVID-19 Vaccines – New Data on Booster of Janssen Vaccine
- COVID-19 Vaccines – FDA Authorizes Pfizer Booster and ACIP Review (Day 2)
- Eli Lilly – Recall of Glucagon® Emergency Kit
- Jakafi® (ruxolitinib) – New indication
- Chantix® (varenicline) – First-time generic
- Opzelura™ (ruxolitinib) – New drug approval
- Bayer – Recall of Lotrimin® AF and Tinactin® spray products
- Livmarli™ (maralixibat) – New orphan drug approval
- Qulipta™ (atogepant) – New drug approval
- Repatha® (evolocumab) – New indication and expanded indication
- Erbitux® (cetuximab) – New indication
- Tasigna® (nilotinib) – Expanded indication
- Tecartus® (brexucabtagene autoleucel) – New indication
- COVID-19 Vaccines and Monoclonal Antibodies – An update
- RxHighlights - September 2021 Edition
- Afinitor Disperz® (everolimus) – First-time generic
- Lupin – Recall of irbesartan and irbesartan/hydrochlorothiazide (HCTZ)
- Tavneos™ (avacopan) – New orphan drug approval
- Rethymic® (allogeneic processed thymus tissue-agdc) – New orphan drug approval
- Teligent Pharma – Recall of lidocaine topical solution
- COVID-19 Vaccines – FDA Advisors Discuss Vaccine Boosters at 2 Day Meeting
- Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide) – Expanded indication, new strength
- Dextenza® (dexamethasone ophthalmic insert) – New indication
- Keytruda® (pembrolizumab) – Expanded indication
- Molnupiravir – An oral treatment for COVID-19 filed for EUA
- Tecentriq® (atezolizumab) – Expanded indication
- Verzenio® (abemaciclib) – New indication, expanded indication
- Cyltezo® (adalimumab-adbm) – First interchangeable biosimilar to Humira
- Zimhi™ (naloxone) – New drug approval
- Tyrvaya™ (varenicline) – New drug approval
- COVID-19 Vaccines – FDA authorizes Moderna, Janssen boosters and “mix and match” vaccines
- COVID-19 Vaccines – CDC’s ACIP votes to recommend vaccine boosters
- Merck – Recall of Cubicin® (daptomycin)
- COVID-19 Vaccines – FDA advisors discuss Pfizer/BioNTech’s vaccine for patients 5 to 12 years
- Bryant Ranch Prepack – Recall of methocarbamol
- Pepaxto® (melphalan flufenamide) – Withdrawal from the U.S. market
- Seglentis® (celecoxib/tramadol) – New drug approval
- Susvimo™ (ranibizumab) – New drug approval
- Xipere® (triamcinolone acetonide) – New drug approval
- Dupixent® (dupilumab) – Expanded indication
- Flucelvax® Quadrivalent (influenza vaccine) – Expanded indication
- Vimpat® (lacosamide) – Expanded indication
- Pfizer/BioNTech COVID-19 Vaccine – Expanded emergency use authorization
- CSL Behring – Withdrawal of Hizentra® [immune globulin subcutaneous (human)]
- Pfizer/BioNTech COVID vaccine – CDC’s ACIP votes to recommend vaccine for children 5 –11 years of age
- Antara® (fenofibrate) – First-time authorized brand alternative
- Scemblix® (asciminib) – New orphan drug approval
- Vuity™ (pilocarpine) – New drug approval
- RxHighlights - October 2021 Edition
- Dyanavel® XR (amphetamine) – New formulation approval
- Eprontia™ (topiramate) – New drug approval
- Purified Cortrophin™ Gel (repository corticotropin) – New drug approval
- Long-Term Drug Shortage – Nefazodone
- Besremi®(ropeginterferon alfa-2b-njft) – New orphan drug approval
- Semglee®(insulin glargine-yfgn) – First interchangeable biosimilar launch
- Roszet®(rosuvastatin/ezetimibe) – First-time authorized brand alternative
- Pfizer/BioNTech and Moderna COVID-19 vaccines – Expanded emergency use authorization and ACIP recommendations
- Oral JAK Inhibitors (Xeljanz®/XR, Olumiant®, Rinvoq®) – Updated labeling
- Dhivy™(carbidopa/levodopa) – New drug approval
- RxOutlook - 4th Quarter 2021
- molnupiravir – FDA’s Antimicrobial Drugs Advisory Committee Review
- Injectafer® (ferric carboxymaltose) – New indication
- Fyarro™ (sirolimus protein-bound particles) (albumin-bound) – New orphan drug approval
- Voxzogo™ (vosoritide) – New orphan drug approval
- Lyvispah™ (baclofen) – New drug approval
- Livtencity™ (maribavir) – New orphan drug approval
- Sagent – Recall of levetiracetam injection
- Arranon® (nelarabine) – First-time generic
- Sandoz – Recall of enoxaparin injection
- Teligent Pharma – Recall of lidocaine topical solution
- Darzalex Faspro® (daratumumab/hyaluronidase-fihj), Kyprolis® (carfilzomib) – Expanded indication
- Evusheld™ (tixagevimab/cilgavimab) – Emergency use authorization
- Epiduo® Forte (adapalene/benzoyl peroxide) – First-time authorized brand alternative
- PreHevbrio™ (hepatitis B vaccine [recombinant]) – New vaccine approval
- Xaciato™ (clindamycin) – New drug approval
- Gilead Sciences – Recall of Veklury® (remdesivir)
- Methyldopa – Long-term drug shortage
- Farydak® (panobinostat) – Voluntary withdrawal
- RxHighlights - November 2021 Edition
- Pfizer/BioNTech COVID-19 Vaccine – Expanded emergency use authorization
- Zepatier® (elbasvir/grazoprevir) – Expanded indication
- Siklos® (hydroxyurea) – Expanded indication
- Pfizer/BioNTech COVID-19 Vaccine – CDC recommends boosters in 16 – 17-year-olds
- Entadfi™ (finasteride/tadalafil) – New drug approval
- Carbaglu® (carglumic acid) – First-time generic
- Janssen COVID-19 Vaccine – CDC updates recommendation
- Yusimry™ (adalimumab-aqvh) – New biosimilar approval
- Vyvgart™ (efgartigimod alfa-fcab) – New orphan drug approval
- Tezspire™ (tezepelumab-ekko) – New drug approval
- Lastacaft® (alcaftadine) – New over-the-counter approval
- Xeljanz® (tofacitinib), Xeljanz XR (tofacitinib) – New indication
- Tarpeyo™ (budesonide) – New orphan drug approval
- Rinvoq® (upadacitinib) – New indication
- Orencia® (abatacept) – New orphan indication
- Kisqali® (ribociclib), Kisqali Femara® Co-Pack – Expanded indication
- Dexilant® (dexlansoprazole) – First-time authorized brand alternative
- Dartisla ODT™ (glycopyrrolate) – New drug approval
- Caplyta® (lumateperone) – New indication
- Paxlovid™ (nirmatrelvir/ritonavir) – Emergency use authorization
- molnupiravir – Emergency use authorization
- Padagis – Recall of nitroglycerin lingual spray
- Narcan® (naloxone) – First-time generic
- Apretude™ (cabotegravir) – New drug approval
- Leqvio® (inclisiran) – New drug approval
- Otezla® (apremilast) – Expanded indication
- Cosentyx® (secukinumab) – New indication, expanded indication
- Oxbryta® (voxelotor) – Expanded indication, new formulation approval
- Lanreotide injection – New drug approval
- Rezvoglar™ (insulin glargine-aglr) – New biosimilar approval
- Xarelto® (rivaroxaban) – New indications, new formulation approval
- Taro – Recall of clobetasol ointment
- Pfizer/BioNTech COVID-19 Vaccine – Expanded emergency use authorization
- CSL Behring – Withdrawal of Hizentra® [immune globulin subcutaneous (human)]
- Rexulti® (brexpiprazole) – Expanded indication
- Tascenso ODT™ (fingolimod) – New formulation approval
- Adbry™ (tralokinumab-ldrm) – New drug approval
- Recorlev® (levoketoconazole) – New orphan drug approval
- Pfizer/BioNTech COVID-19 Vaccine – CDC recommends boosters in 12 – 15 year olds
- RxHighlights - December 2021 Edition
- Viona – Recall of metformin
- CSL Behring – Withdrawal of Hizentra® [immune globulin subcutaneous (human)]
- Vasostrict® (vasopressin) – First-time generic
- Moderna COVID-19 Vaccine – Expanded emergency use authorization
- Quviviq™ (daridorexant) – New drug approval
- Lohxa – Recall of senna syrup
- Descovy® (emtricitabine/tenofovir alafenamide) – Expanded indication, new strength
- Rinvoq® (upadacitinib) – New indication
- Cibinqo® (abrocitinib) – New drug approval
- Ryaltris™ (olopatadine/mometasone furoate monohydrate) – New drug approval
- Buprenorphine-containing transmucosal drugs – Safety update
- Cuvposa® (glycopyrrolate) – First-time generic
- Mylan – Recall of Semglee® (insulin glargine injection)
- bamlanivimab/etesevimab and REGN-COV (casirivimab/imdevimab) – Emergency use authorization revision
- Veklury® (remdesivir) – Revised emergency use authorization
- Veklury® (remdesivir) – Expanded indication
- Skyrizi® (risankizumab-rzaa) – New indication
- Zydelig® (idelalisib) – Indication withdrawals
- Combigan® (brimonidine/timolol) – First-time authorized brand alternative
- Novo Nordisk – Shortage of Wegovy® (semaglutide)
- AuroMedics – Recall of polymyxin B for injection
- Blaine Labs – Recall of RevitaDerm® (benzalkonium chloride)
- Kimmtrak® (tebentafusp-tebn) – New orphan drug approval
- Spikevax™ (COVID-19 vaccine, mRNA) – New vaccine approval
- Vabysmo™ (faricimab-svoa) – New drug approval
- Solosec® (secnidazole) – Expanded indication
- Pifeltro™ (doravirine), Delstrigo™ (doravirine/lamivudine/tenofovir disoproxil fumarate) – Expanded indications
- Vonvendi® (von Willebrand factor [recombinant]) – New indication
- Spikevax™ (COVID-19 vaccine, mRNA) – CDC’s ACIP votes to recommend vaccine for adults 18 years of age and older
- RxHighlights - January 2022 Edition
- Restasis® (cyclosporine) – First-time generic
- Intron® A (interferon alfa-2b) – Product discontinuation
- Enjaymo™ (sutimlimab-jome) – New orphan drug approval
- Fleqsuvy™ (baclofen) – New drug approval
- Ukoniq® (umbralisib) – Drug safety communication
- bebtelovimab – Emergency use authorization approval
- Selzentry® (maraviroc) – First-time generic
- RxOutlook - 1st Quarter 2022
- Abbott – Recall of Similac®, Alimentum®, EleCare® infant formula
- Pyrukynd® (mitapivat) – New orphan drug approval
- Drug Shortage – Lacrisert® (hydroxypropyl cellulose ophthalmic insert)
- Norliqva® (amlodipine) – New drug approval
- AmBisome® (amphotericin B) – First-time generic
- Jardiance® (empagliflozin) – Expanded indication
- Releuko® (filgrastim-ayow) – New biosimilar approval
- Vonjo™ (pacritinib) – New orphan drug approval
- Carvykti™ (ciltacabtagene autoleucel) – New orphan drug approval
- Fresenius Kabi – Recall of sodium acetate injection
- Aspruzyo Sprinkle™ (ranolazine) – New drug approval
- Revlimid® (lenalidomide) – First-time generic
- Actemra® (tocilizumab) – Updated labeling
- Opdivo® (nivolumab) – New indication
- RxHighlights - February 2022 Edition
- Lynparza® (olaparib) – New indication
- Adlarity® (donepezil) – New drug approval
- Golden State Medical Supply – Recall of enalapril tablets
- Pfizer – Recall of Accuretic™ (quinapril/hydrochlorothiazide [HCTZ]), quinapril and HCTZ, and quinapril HCl/HCTZ
- Sandoz – Recall of orphenadrine
- Adamis – Recall of Symjepi® (epinephrine) injection
- Nasonex® (mometasone furoate monohydrate) – New partial over-the-counter approval
- Opdualag™ (nivolumab/relatlimab-rmbw) – New drug approval
- Ztalmy® (ganaxolone) – New orphan drug approval
- Vimpat® (lacosamide) – First-time generic
- Keytruda® (pembrolizumab) – Expanded indication
- Rinvoq® (upadacitinib) – New indication
- Plastikon Healthcare – Recall of Milk of Magnesia, acetaminophen, and magnesium hydroxide/aluminum hydroxide/simethicone products
- Apokyn® (apomorphine) – First-time generic
- 2nd booster of Pfizer/BioNTech and Moderna COVID-19 vaccines – Expanded emergency use authorization
- Fintepla® (fenfluramine) – New indication
- Ozempic® (semaglutide) – New strength
- Xelstrym™ (dextroamphetamine) – New drug approval
- Hyftor™ (sirolimus) – New drug approval
- Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) – New drug approval
- Tlando™ (testosterone undecanoate) – New drug approval
- Zipsor® (diclofenac potassium) – First-time generic
- CDC recommendations for COVID-19 vaccine 2nd booster doses
- Teva – Recall of Idarubicin injection
- AMX0035 for ALS – FDA Advisory Committee Update
- Sotrovimab – Emergency use authorization revision
- Cabenuva (cabotegravir/rilpivirine) – New indication
- Yescarta® (axicabtagene ciloleucel) – Expanded indication
- RxHighlights - March 2022 Edition
- COVID-19 Vaccines – FDA Advisors Discuss Vaccine Boosters and Future COVID-19 Vaccine Strain Selection
- CMS announces final Medicare national coverage determination for Aduhelm™ (aducanumab)
- Abbott – Recall of Similac®, Alimentum®, EleCare® infant formula
- Mylan/Viatris – Recall of insulin glargine (insulin glargine-yfgn)
- Igalmi™ (dexmedetomidine) – New drug approval
- Vijoice® (alpelisib) – New orphan drug approval
- Alymsys® (bevacizumab-maly) – New biosimilar approval
- Ukoniq™ (umbralisib) – Voluntary withdrawal
- CDC’s ACIP meets to discuss COVID-19 vaccine boosters
- Pfizer – Recall of Accupril™ (quinapril)
- Caplyta® (lumateperone) – New dosage strengths
- Epsolay® (benzoyl peroxide) – New drug approval
- Bidil® (isosorbide dinitrate/hydralazine) – First-time generic
- Veklury® (remdesivir) – Expanded indication
- Zerbaxa® (ceftolozane/tazobactam) – Expanded indication
- Vimpat® (lacosamide) – First-time generic
- Glenmark – Recall of arformoterol inhalation solution
- Glenmark – Recall of naproxen tablets
- Glenmark – Recall of zonisamide capsules
- Rinvoq® (upadacitinib) – New indication
- Qelbree® (viloxazine) – Expanded indication
- Ninlaro® (ixazomib) – Updated labeling
- Abraxane® (paclitaxel, protein-bound) – First-time authorized brand alternative
- Vivjoa™ (oteseconazole) – New drug approval
- Ultomiris® (ravulizumab-cwvz) – New orphan indication
- Cuvrior™ (trientine tetrahydrochloride) – New orphan drug approval
- Camzyos™ (mavacamten) – New orphan drug approval
- Glenmark – Recall of chlorzoxazone
- RxHighlights - April 2022 Edition
- Ermeza™ (levothyroxine) – New drug approval
- Voquezna™ Triple Pak™ (vonoprazan, amoxicillin, clarithromycin), Voquezna Dual Pak™ (vonoprazan, amoxicillin) – New drug approval
- Esbriet® (pirfenidone) – First-time generic
- Velcade® (bortezomib) – First-time generic
- Janssen COVID-19 Vaccine – Revised emergency use authorization (EUA)
- Enhertu® (fam-trastuzumab deruxtecan-nxki) – Expanded indication
- Moderna COVID-19 vaccine – FDA advisors discuss emergency use authorization request for 6 - 17 years of age
- Pfizer and Moderna COVID-19 vaccines – FDA advisors discuss emergency use authorization request for children 6 months to 4 or 5 years
- Booster of Pfizer/BioNTech vaccine – Expanded emergency use authorization in 5 – 11 years of age.
- Pfizer/BioNTech and Moderna COVID-19 vaccines – CDC recommends primary series in 6 months to 4 or 5 years of age
- Olumiant® (baricitinib) – New indication
- Moderna COVID-19 vaccine – EUA granted for 6 months to 17 years
- Pfizer/BioNTech COVID-19 vaccine – EUA granted for 6 months to 4 years
- Pfizer/BioNTech COVID-19 vaccine – CDC recommends booster dose in 5 – 11 years of age
- Alzheimer’s disease pipeline update – Lecanemab
- Relyvrio™ (sodium phenylbutyrate/taurursodiol) – New orphan drug approval
- Mounjaro™ (tirzepatide) – New drug approval
- Radicava ORS® (edaravone) – New orphan drug approval
- Teva – Recall of anagrelide
- TG Therapeutics – Withdrawal of Ukoniq® (umbralisib)
- Skyrizi® (risankizumab-rzaa) – New indication, new formulation approval
- Tyvaso DPI™ (treprostinil) – New drug approval
- Imcivree® (setmelanotide) – New orphan indication
- Zulresso® (brexanolone) – Expanded indication
- Vtama® (tapinarof) – New drug approval
- Alfasigma – Withdrawal of Zelnorm® (tegaserod)
- Bryant Ranch Prepack – Recall of morphine extended-release tablets
- Vi-Jon – Recall of CVS magnesium citrate saline laxative oral solution
- Pheburane® (sodium phenylbutyrate) – New orphan drug approval
- Relexxii® (methylphenidate hydrochloride extended-release) – New drug approval
- Breyanzi® (lisocabtagene maraleucel) – Expanded indications
- Qsymia® (phentermine/topiramate extended-release) – Expanded indication
- Tafinlar® (dabrafenib), Mekinist® (trametinib) – New indication
- Pennsaid® (diclofenac sodium) – First-time generic
- COVID-19 vaccines – FDA advisors discuss composition of vaccines for booster doses in the Fall 2022
- Mylan – Recall of insulin glargine
- Daytrana® (methylphenidate) – First-time generic
- Copiktra® (duvelisib) – Drug safety communication
- Kyprolis® (carfilzomib) – Expanded indication
- Monkeypox – Update
- Vi-Jon – Expanded Recall of magnesium citrate saline laxative oral solution
- Zonisade™ (zonisamide) – New drug approval
- Vi-Jon – Expanded Recall of magnesium citrate saline laxative oral solution
- Opzelura® (ruxolitinib) – New indication
- Novavax COVID-19 vaccine, adjuvanted – New emergency use authorization
- Xalkori® (crizotinib) – New indication
- Kyzatrex® (testosterone undecanoate) – New drug approval
- Ultomiris® (ravulizumab-cwvz) – New formulation approval
- Zoryve™ (roflumilast) – New drug approval
- Benlysta® (belimumab) – Expanded indication
- Fylnetra™ (pegfilgrastim-pbbk) – New biosimilar approval
- Stelara® (ustekinumab) – Expanded indication
- Vi-Jon – Expanded recall of magnesium citrate saline laxative oral solution
- Plastikon Healthcare – Recall of magnesium hydroxide/aluminum hydroxide/simethicone
- Calquence® (acalabrutinib) – New formulation approval
- Enhertu® (fam-trastuzumab deruxtecan-nxki) – New indication
- Myfembree® (relugolix/estradiol/norethindrone acetate) – New indication
- Alimta® (pemetrexed disodium) – First-time generic
- Targretin® (bexarotene) – First-time generic
- Vimpat® (lacosamide) – First-time generic
- Breo® Ellipta® (fluticasone furoate/vilanterol trifenatate) – First-time authorized brand alternative
- FloventM® HFA® (fluticasone propionate) – First-time authorized brand alternative
- Nubeqa® (darolutamide) – Expanded indication
- RxHighlights - July 2022 Edition
- Evrysdi® (risdiplam) – Expanded indication
- Lyons Magnus – Recall of various nutritional and beverage products
- Abbott – Recall of various nutritional products
- Kymriah® (tisagenlecleucel) – New indication
- Enhertu® (fam-trastuzumab deruxtecan-nxki) – New indication
- Opdivo® (nivolumab), Yervoy® (ipilimumab) – New indications
- Jynneos® (smallpox and monkeypox vaccine, live, nonreplicating) – Emergency use authorization granted
- Mirena® (levonorgestrel-releasing intrauterine system) – Expanded indication
- Tibsovo® (ivosidenib) – Expanded indication
- Xofluza® (baloxavir marboxil) – Expanded indications
- Auvelity™ (dextromethorphan/bupropion) – New drug approval
- Hadlima™ (adalimumab-bwwd) – New biosimilar strength approval
- Zynteglo® (betibeglogene autotemcel) – New orphan drug approval
- Novavax COVID-19 vaccine, adjuvanted – Expanded emergency use authorization
- COVID-19 bivalent booster vaccines – Update
- Imbruvica® (ibrutinib) – Expanded indication, new formulation approval
- Pentasa® (mesalamine) – First-time generic
- Pemazyre® (pemigatinib) – New indication
- Moderna and Pfizer/BioNTech COVID-19 vaccines, bivalent (Original and Omicron BA.4/BA.5) – New emergency use authorizations
- Dupixent® (dupilumab) – New indication
- Vidaza® (azacitidine) – New indication
- AMX-0035 for amyotrophic lateral sclerosis (ALS) – FDA Advisory Committee update
- Imfinzi® (durvalumab) – New orphan indication
- Plastikon Healthcare – Recall of Milk of Magnesia and magnesium hydroxide/aluminum hydroxide/simethicone products
- Konvomep™ (omeprazole/sodium bicarbonate) – New drug approval
- Spevigo® (spesolimab-sbzo) – New orphan drug approval
- Stimufend® (pegfilgrastim-fpgk) – New biosimilar approval
- Xenpozyme™ (olipudase alfa-rpcp) – New orphan drug approval
- Lynparza® (olaparib) – Voluntary indication withdrawal
- Pfizer/BioNTech and Moderna COVID-19 vaccines, bivalent – CDC recommends bivalent booster dose
- Orkambi® (lumacaftor/ivacaftor) – Expanded indication, new strength
- Daxxify™ (daxibotulinumtoxinA-lanm) – New drug approval
- Rolvedon™ (eflapegrastim-xnst) – New drug approval
- Sotyktu™ (deucravacitinib) – New drug approval
- RxHighlights - August 2022 Edition
- Aponvie™ (aprepitant) – New drug approval
- Skysona® (elivaldogene autotemcel) – New orphan drug approval
- Terlivaz® (terlipressin) – New orphan drug approval
- Pradaxa® (dabigatran etexilate) – First-time generic
- Tazorac® (tazarotene) – First-time generic
- Zejula® (niraparib) – Indication removal
- Omlonti® (omidenepag isopropyl) – New drug approval
- Pedmark® (sodium thiosulfate) – New orphan drug approval
- Retevmo® (selpercatinib) – New indication
- Glenmark – Recall of chlorzoxazone
- Amvuttra (vutrisiran) – New orphan drug approval
- Nexavar® (sorafenib) – First-time generic
- CellCept® (mycophenolate mofetil) – Expanded indication
- Dupixent® (dupilumab) – Expanded indication
- Byooviz™ (ranibizumab-nuna) – New biosimilar launch
- Pfizer – Recall of aminophylline injection
- Golden State Medical Supply – Recall of atenolol and clopidogrel
- Priorix (measles, mumps, and rubella vaccine, live) – New vaccine approval
- Gene therapy - FDA Advisory Committee update
- Lytgobi® (futibatinib) – New orphan drug approval
- Viibryd® (vilazodone) – First-time generic
- Tresiba® (insulin degludec) – First-time authorized brand alternative
- Olumiant (baricitinib) - New indication
- Beovu® (brolucizumab-dbll) – New indication
- Vegzelma® (bevacizumab-adcd) – New biosimilar approval
- Gilenya® (fingolimod) – First-time generic
- Dupixent® (dupilumab) – New indication
- Firdapse® (amifampridine) – Expanded indication
- Furoscix® (furosemide) – New drug approval
- Divigel® (estradiol) – First-time generic
- Rubraca® (rucaparib) - Voluntary indication withdrawal
- Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) – New indication
- Oxlumo™ (lumasiran) – Expanded indication
- Moderna and Pfizer/BioNTech COVID-19 vaccines, bivalent boosters— Updated emergency use authorizations and CDC approval
- RxHighlights - September 2022 Edition
- Novavax COVID-19 vaccine – FDA advisors discuss emergency use authorization request
- Exela Pharma Sciences – Recall of sodium bicarbonate injection
- Abbott – Recall of ready-to-feed liquid products
- Lyumjev® (insulin lispro-aabc) – Expanded indication
- Novavax COVID-19 vaccine, adjuvanted – Booster dose emergency use authorization
- Food and Drug Administration – Shortage of amphetamine mixed salts
- Vemlidy® (tenofovir alafenamide) – Expanded indication
- Rinvoq® (upadacitinib) – New indication
- Aurobindo – Recall of quinapril/hydrochlorothiazide
- Imjudo® (tremelimumab-actl) – New drug approval
- Tecvayli™(teclistamab-cqyv) – New drug approval
- Cetrotide® (cetrorelix) – First-time generic
- Daliresp® (roflumilast) – First-time generic
- Cotellic® (cobimetinib) – New orphan indication
- Ferring – Temporary Discontinuation of Menopur® (menotropins for injection)
- Kineret® (anakinra) – Emergency use authorization granted
- RxHighlights - October 2022 Edition
- Elahere™ (mirvetuximab soravtansine-gynx) – New orphan drug approval
- Denavir® (penciclovir) – First-time generic
- Adcetris® (brentuximab vedotin) – New indication
- Imfinzi® (durvalumab) plus Imjudo® (tremelimumab-actl) – New indication
- Libtayo® (cemiplimab-rwlc) – Expanded indication
- Liletta® (levonorgestrel-releasing intrauterine system) – Expanded indication
- Helsinn Therapeutics – Discontinuation of Truseltiq® (infigratinib)
- RxOutlook - 2nd Quarter 2022
- RxOutlook - 3rd Quarter 2022
- RxOutlook - 4th Quarter 2022
- Insulet – Recall of Omnipod DASH Insulin Management System
- Rezvoglar™ (insulin glargine-aglr) – New interchangeable biosimilar approval
- Tzield™ (teplizumab-mzwv) – New drug approval
- Zioptan® (tafluprost) – First-time authorized brand alternative
- Zejula® (niraparib) – Indication update
- Trulicity® (dulaglutide) – Expanded indication
- Hemgenix® (etranacogene dezaparvovec-drlb) – New orphan drug approval
- Exela Pharma Sciences – Recall of sodium bicarbonate injection
- GSK – Discontinuation of Blenrep® (belantamab mafodotin-blmf)
- Folotyn® (pralatrexate) – First-time authorized brand alternative
- Sezaby™ (phenobarbital) – New orphan drug approval
- Prolia® (denosumab) – FDA drug safety communication
- Lecanemab – Updated clinical data indicate a modest clinical effect on the disease, with a moderate rate of serious adverse events.
- Tecentriq® (atezolizumab) – Indication withdrawal
- Brexafemme® (ibrexafungerp) – New indication
- Jylamvo® (methotrexate) – New drug approval
- Rebyota™ (fecal microbiota, live - jslm) – New orphan drug approval
- Rezlidhia™ (olutasidenib) – New orphan drug approval
- Moderna and Pfizer/BioNTech COVID-19 vaccines, bivalent authorized down to 6 months old – Updated emergency use authorizations
- Idacio® (adalimumab-aacf) – New biosimilar approval
- Krazati™ (adagrasib) – New orphan drug approval
- Treanda® (bendamustine) – First-time generic
- Moderna and Pfizer/BioNTech COVID-19 vaccines, bivalent authorized down to 6 months old – CDC approves
- Ibrance® (palbociclib) – Updated label
- Tascenso ODT® (fingolimod) – Expanded indication, new strength
- Tecentriq® (atezolizumab) – New orphan indication
- Zejula® (niraparib) – Indication update
- RxHighlights - November 2022 Edition
- Adstiladrin® (nadofaragene firadenovec-vncg) – New drug approval
- Iyuzeh™ (latanoprost) – New drug approval
- Vraylar® (cariprazine) – New indication
- Xeloda® (capecitabine) – New and expanded indications
- Lupin – Recall of quinapril
- Accord Healthcare – Recall of daptomycin injection
- Various manufacturers – Supply of amoxicillin oral products
- Various manufacturers – Supply of generic Tamiflu® (oseltamivir)
- Federal government releases supply of Tamiflu® (oseltamivir) from national stockpile to address shortage
- Briumvi™ (ublituximab-xiiy) – New drug approval
- Keytruda® (pembrolizumab) – Accelerated approval to full approval
- Lunsumio™ (mosunetuzumab-axgb) – New orphan drug approval
- Olpruva™ (sodium phenylbutyrate) – New drug approval
- Sunlenca® (lenacapavir) – New drug approval
- Actemra® (tocilizumab) – New indication
- Avycaz® (ceftazidime/avibactam) – Expanded indication
- Pemfexy™ (pemetrexed) – New indication
- Tymlos® (abaloparatide) – New indication
- Wegovy® (semaglutide) – Expanded indication
- Eugia – Recall of acyclovir injection
- Cambia® (diclofenac potassium) – First-time authorized brand alternative
- NexoBrid® (anacaulase-bcdb) – New orphan drug approval
- Xyrem® (sodium oxybate) – First-time authorized brand alternative
- Rubraca® (rucaparib) – Indication update
- Leqembi™ (lecanemab-irmb) for Alzheimer’s disease – New drug approval
- Spectrum Laboratory Products – Recall of epinephrine USP bulk powder
- Airsupra™ (albuterol/budesonide) – New drug approval
- Liptruzet® (atorvastatin/ezetimibe) – First-time generic
- Mirvaso® (brimonidine) – First-time generic
- Trokendi XR® (topiramate) – First-time generic
- RxHighlights - December 2022 Edition
- Sanofi – Discontinuation of Adlyxin® (lixisenatide)
- AstraZeneca – Discontinuation of Lumoxiti® (moxetumomab pasudotox-tdfk)
- Rykindo® (risperidone) – New drug approval
- Esbriet® (pirfenidone) – First-time generic
- Adacel® (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) – New indication
- Brenzavvy™ (bexagliflozin) – New drug approval
- Brukinsa® (zanubrutinib) – New indication
- Tukysa® (tucatinib) – New indication
- Jaypirca™ (pirtobrutinib) – New drug approval
- Orserdu™ (elacestrant) – New drug approval
- Enjaymo™ (sutimlimab-jome) – Updated indication
- Keytruda® (pembrolizumab) – New indication
- Odactra™ House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) – Expanded indication
- IBSA Pharma – Recall of TIROSINT®-SOL (levothyroxine sodium) oral solution
- RxHighlights - January 2023 Edition
- Global Pharma Healthcare – Recall of Artificial Tears Lubricant Eye Drops
- Atorvaliq® (atorvastatin) – New drug approval
- Jesduvroq (daprodustat) – New drug approval
- Tezspire® (teplizumab-ekko) – New dosage formulation
- Hetlioz® (tasimelteon) – First-time generic update
- Keveyis® (dichlorphenamide) – First-time generic
- Revatio® (sildenafil) – Expanded indication
- Takhzyro® (lanadelumab-flyo) – Expanded indication
- Trodelvy® (sacituzumab govitecan-hziy) – New indication
- Nationwide Pharmaceutical – Recall of ferrous sulfate tablets
- BD – Recall of BD Insulin Syringes with the BD Micro-Fine™ IV Needle
- B. Braun Medical – Recall of sodium chloride injection
- Cibinqo® (abrocitinib) – Expanded indication
- Eylea® (aflibercept) – New orphan indication
- Jemperli (dostarlimab-gxly) – Updated indication
- RxOutlook - 1st Quarter 2023
- Reckitt – Recall of Enfamil Prosobee® Simply Plant-Based Infant Formula
- Austedo® XR (deutetrabenazine) – New formulation approval
- Filspari™ (sparsentan) – New orphan drug approval
- Lamzede® (velmanase alfa-tycv) – New orphan drug approval
- Syfovre™ (pegcetacoplan) – New drug approval
- Latuda® (lurasidone) – First-time generic
- Opdivo® (nivolumab) – Expanded indications
- Yervoy® (ipilimumab) – Expanded indication
- Global Pharma Healthcare – Recall of Artificial Eye Ointment
- Altuviiio™ (antihemophilic factor [recombinant], Fc-VWF-XTEN fusion protein-ehtl) – New orphan drug approval
- Advair HFA® (fluticasone/salmeterol) – First-time authorized brand alternative
- Bivalent mRNA COVID-19 vaccines – ACIP discusses transitioning to bivalent primary series
- Kevzara® (sarilumab) – New indication
- Sagent – Recall of heparin sodium injection
- Apotex – Recall of brimonidine tartrate ophthalmic solution
- Combogesic® (acetaminophen/ibuprofen) – New drug approval
- Leqembi™ (lecanemab-irmb) – FDA accepts application for traditional approval
- Verzenio® (abemaciclib) – Expanded indication
- RxHighlights - February 2023 Edition
- Sandoz – Recall of aprepitant capsules and lidocaine/prilocaine cream
- Camber – Recall of atovaquone oral suspension
- Daybue™ (trofinetide) – New orphan drug approval
- Naloxone nasal spray – New drug approval
- Zavzpret™ (zavegepant) – New drug approval
- Aubagio® (teriflunomide) – First-time generic
- Pylera® (bismuth subcitrate potassium/metronidazole/tetracycline) – First-time generic
- Livmarli® (maralixibat) – Expanded indication
- Pfizer/BioNTech COVID-19 vaccine, bivalent – Authorized as booster dose in 6 months – 4 years of age
- Pfizer – Recall of Nurtec® ODT (rimegepant)
- Tafinlar® (dabrafenib) plus Mekinist® (trametinib) – New indication, new formulation approvals
- Hyrimoz® (adalimumab-adaz) – New biosimilar strength approval
- Evkeeza® (evinacumab-dgnb) – Expanded indication
- Paxlovid™ (nirmatrelvir/ritonavir) – FDA’s Antimicrobial Drugs Advisory Committee recommends Paxlovid
- Ascend – Recall of dabigatran etexilate capsules
- Joenja® (leniolisib) – New orphan drug approval
- Rezzayo™ (rezafungin) – New drug approval
- Zynyz™ (retifanlimab-dlwr) – New drug approval
- Narcan® (naloxone) – New over-the-counter approval
- Keytruda® (pembrolizumab) plus Padcev® (enfortumab vedotin-ejfv) – New indication
- Gohibic™ (vilobelimab) – New emergency use authorization
- Firvanq® Kit (vancomycin) – First-time authorized brand alternative
- FDA announces decision to withdraw Makena (hydroxyprogesterone caproate)
- Imbruvica® (ibrutinib) – Indication withdrawals
- RizaFilm® (rizatriptan) – New drug approval
- Bivalent mRNA COVID-19 vaccines – ACIP discusses FDA updates to bivalent mRNA vaccine schedules
- COVID-19 bivalent booster vaccines – Update
- Hyqvia® (immune globulin infusion 10% [human] with recombinant human hyaluronidase) – Expanded Indication
- Tepezza® (teprotumumab-trbw) – Updated indication
- Qulipta® (atogepant) – Expanded indication
- Polivy® (polatuzumab vedotin-piiq) – New indication
- Omisirge® (omidubicel-onlv) – New orphan drug approval
- RxHighlights - March 2023 Edition
- Sun – Recall of Fyremadel® (ganirelix acetate) injection
- Qalsody™ (tofersen) – New orphan drug approval
- Coagadex® (coagulation Factor X [human]) – Expanded indication
- Akorn declares bankruptcy – Recalls all drug products
- Teva – Recall of fentanyl buccal tablets
- Abilify Asimtufii® (aripiprazole) – New drug approval
- Fleqsuvy® (baclofen) – First-time authorized brand alternative
- Lumryz™ (sodium oxybate) – New orphan drug approval
- Vowst™ (fecal microbiota spores, live-brpk) – New orphan drug approval
- Zejula® (niraparib) – New formulation approval
- Naftin® (naftifine) – First-time generic
- Uceris® (budesonide) – First-time generic
- Pfizer/BioNTech COVID-19 vaccine, bivalent – Additional dose(s) in 6 months – 4 years with immunocompromise
- Prevnar 20® (pneumococcal 20-valent conjugate vaccine) – New indications
- Trikafta® (elexacaftor/tezacaftor/ivacaftor; ivacaftor) – Expanded indication, new formulation
- Uzedy™ (risperidone) – New drug approval
- Arexvy (respiratory syncytial virus vaccine, adjuvanted) – New vaccine approval
- Liqrev® (sildenafil) – New drug approval
- Motpoly XR (lacosamide) – New drug approval
- Symbicort Aerosphere® (budesonide/formoterol) – New formulation approval
- Iressa® (gefitinib) – First-time generic
- Farxiga® (dapagliflozin) – Expanded indication
- Kalydeco® (ivacaftor) – Expanded indication and new dosage strengths
- Sogroya® (somapacitan-beco) – Expanded indication, new dosage strength
- RxHighlights - April 2023 Edition
- Elfabrio® (pegunigalsidase alfa-iwxj) – New drug approval
- Veozah™ (fezolinetant) – New drug approval
- Breo Ellipta® (fluticasone furoate/vilanterol) – Expanded indication and new strength
- Caldolor® (ibuprofen) – Expanded indication
- Lexapro® (escitalopram) – Expanded indication
- Rexulti® (brexpiprazole) – New indication
- Astral SteriTech – Recalls all antibiotic injectable products
- Novis PR LLC – Recall of G-Supress DX Pediatric Drops
- Brixadi™ (buprenorphine) – New drug approval
- Epkinly™ (epcoritamab-bysp) – New drug approval
- Miebo™ (perfluorohexyloctane) – New drug approval
- Opvee® (nalmefene) – New drug approval
- Vyjuvek™ (beremagene geperpavec-svdt) – New orphan drug approval
- Celontin® (methsuximide) – First-time generic
- Imbruvica® (ibrutinib) – Indication and strength removals
- Rinvoq® (upadacitinib) – New indication
- RxOutlook - 2nd Quarter 2023
- Inpefa® (sotagliflozin) – New drug approval
- Paxlovid® (nirmatrelvir; ritonavir) – New drug approval
- Xacduro® (sulbactam; durlobactam) – New drug approval
- Yuflyma® (adalimumab-aaty) – New biosimilar approval
- Ayvakit® (avapritinib) – New orphan indication
- Abrysvo™ (respiratory syncytial virus vaccine) – New vaccine approval
- Vevye (cyclosporine) – New drug approval
- Prezista® (darunavir) – First-time generic
- Injectafer® (ferric carboxymaltose) – New indication
- Lynparza® (olaparib) – New indication
- Prevymis® (letermovir) – New indication
- Zinplava™ (bezlotoxumab) – Expanded indication
- Aggrastat® (tirofiban) – First-time generic
- Leqembi™ (lecanemab-irmb) – FDA Advisory Committee update
- Linzess® (linaclotide) – New indication
- RxHighlights - May 2023 Edition
- COVID-19 vaccines – VRBPAC makes recommendations for new monovalent vaccine composition
- Major and Rugby – Recall of dronabinol and ziprasidone
- Columvi® (glofitamab-gxbm) – New drug approval
- Lodoco® (colchicine) – New drug approval
- Bylvay® (odevixibat) – New orphan indication
- Triumeq/Triumeq PD (abacavir/dolutegravir/lamivudine) – Expanded indication
- Suflave® (polyethylene glycol 3350/sodium sulfate/potassium chloride/ magnesium sulfate/sodium chloride) – New drug approval
- Vyvgart® Hytrulo (efgartigimod alfa/hyaluronidase-qvfc) – New orphan drug approval
- Ascensia – Recall of Contour® Next Gen Blood Glucose Meters
- Elevidys (delandistrogene moxeparvovec-rokl) – New orphan drug approval
- Litfulo™ (ritlecitinib) – New drug approval
- Rystiggo® (rozanolixizumab-noli) – New orphan drug approval
- Ngenla™ (somatrogon-ghla) – New orphan drug approval
- Jardiance® (empagliflozin), Synjardy® (empagliflozin/metformin) – Expanded indication
- RSV vaccines – CDC Advisory Committee on Immunization Practices update
- Talzenna® (talazoparib) – New indication
- Roctavian™ (valoctocogene roxaparvovec-rvox) – New orphan drug approval
- Noxafil® (posaconazole) – First-time generic
- Gavreto® (pralsetinib) – Indication withdrawal
- Liletta® (levonorgestrel-releasing intrauterine system) – New indication
- Leqembi® (lecanemab-irmb) – Accelerated approval converted to traditional approval
- FDA announces decision to withdraw Oxandrin® (oxandrolone)
- Cipla – Recall of albuterol inhalation aerosol
- B. Braun Medical – Recall of sodium chloride injection
- Leqvio® (inclisiran) – Updated indication
- Nucynta® (tapentadol) – Expanded indication
- RxHighlights - June 2023 Edition
- Beyfortus™ (nirsevimab-alip) – New drug approval
- Opill® (norgestrel) – New over-the-counter approval
- Mozobil® (plerixafor) – First-time authorized brand alternative
- Vanflyta® (quizartinib) – New orphan drug approval
- Xdemvy™ (lotilaner) – New drug approval
- Ycanth™ (cantharidin) – New drug approval
- Wegovy® (semaglutide) – Updated dosing
- Lupin – Recall of Tydemy™ (drospirenone/ethinyl estradiol and levomefolate)
- RiVive™ (naloxone) – New over-the-counter approval
- Symbicort® (budesonide/formoterol) – First-time generic
- Jemperli® (dostarlimab-gxly) – New indication
- B. Braun Medical – Recall of sodium chloride injection
- Izervay™ (avacincaptad pegol) – New drug approval
- Zurzuvae™ (zuranolone) – New drug approval
- Onglyza® (saxagliptin) – First-time generic
- Lonsurf® (trifluridine/tipiracil) – Expanded indication
- Prevymis® (letermovir) – Updated label
- Ritedose – Recall of cromolyn oral solution
- Akeega™ (niraparib/abiraterone) – New drug approval
- Elrexfio™ (elranatamab-bcmm) – New orphan drug approval
- Hepzato Kit™ (melphalan/hepatic delivery system) – New drug approval
- Talvey™ (talquetamab-tgvs) – New orphan drug approval
- Kombiglyze® XR (saxagliptin/metformin, extended release) – First-time generic
- RxHighlights - July 2023 Edition
- Eylea® HD (aflibercept) – New formulation approval
- Sohonos™ (palovarotene) – New orphan drug approval
- Veopoz™ (pozelimab-bbfg) – New orphan drug approval
- Balcoltra™ (levonorgestrel/ethinyl estradiol and ferrous bisglycinate) – First-time generic
- Spiriva® HandiHaler® (tiotropium) – First-time generic
- Abrysvo™ (respiratory syncytial virus vaccine) – New indication
- RxOutlook - 3rd Quarter 2023
- Focinvez™ (fosaprepitant) – New drug approval
- Tyruko® (natalizumab-sztn) – New first-time biosimilar approval
- Vyvanse® (lisdexamfetamine) – First-time generic
- Ilaris® (canakinumab) – New indication
- Reblozyl® (luspatercept-aamt) – Expanded indication
- Marlex – Recall of digoxin tablets
- Alphagan® P (brimonidine) – First-time generic
- Mekinist® (trametinib) plus Tafinlar® (dabrafenib) – Expanded indication
- Pfizer/BioNTech and Moderna COVID-19 vaccines (Omicron variant XBB.1.5) – CDC recommends updated vaccine
- Novartis – Recall of Sandimmune® (cyclosporine) oral solution
- Aphexda™ (motixafortide) – New orphan drug approval
- Xalkori® (crizotinib) – New formulation approval
- Comirnaty® and Spikevax® (Omicron XBB.1.5) vaccines – FDA approval and Emergency Use Authorization
- RxHighlights - August 2023 Edition
- Ojjaara (momelotinib) – New orphan drug approval
- Temodar® (temozolomide) – Updated indication
- Food and Drug Administration – Shortage of Vyvanse® (lisdexamfetamine) and generics
- VistaPharm – Recall of sucralfate oral suspension
- Exxua (gepirone) – New drug approval
- Likmez™ (metronidazole) – New drug approval
- Jardiance® (empagliflozin) – New indication
- Scynexis – Recall of Brexafemme® (ibrexafungerp)
- KVK Tech – Recall of betaxolol tablets
- Hospira – Recall of sodium injection and lidocaine injection
- Bosulif® (bosutinib) – Expanded indication, new formulation approval
- Entyvio® (vedolizumab) – New formulation approval
- Pombiliti™ (cipaglucosidase alfa-atga) plus Opfolda™ (miglustat) – New drug approvals
- Rivfloza™ (nedosiran) – New orphan drug approval
- Tofidence™ (tocilizumab-bavi) – New biosimilar approval
- Cyltezo® (adalimumab-adbm) and unbranded adalimumab-adbm – Clarification about formulary status
- Exkivity® (mobocertinib) – Drug withdrawal
- Cosentyx® (secukinumab) – New formulation approval
- Onexton® (clindamycin/benzoyl peroxide) – First-time generic
- Novavax COVID-19 vaccine, adjuvanted (2023-2024 formula) – Emergency Use Authorization
- Zoryve ® (roflumilast) – Expanded indication
- Fresenius Kabi – FDA authorizes foreign importation of cisplatin
- Velsipity™ (etrasimod) – New drug approval
- Mydayis® (mixed-salts of a single-entity amphetamine product) – First-time generic
- Veltassa® (patiromer) – Expanded indication, new strength
- Braftovi® (encorafenib) plus Mektovi® (binimetinib) – New indication
- Keytruda® (pembrolizumab) – Expanded indication
- Opdivo® (nivolumab) – Expanded indication
- RxHighlights - September 2023 Edition
- Bimzelx® (bimekizumab-bkzx) – New drug approval
- Combogesic® IV (acetaminophen/ibuprofen) – New drug approval
- Coxanto (oxaprozin) – New drug approval
- Qlosi™ (pilocarpine) – New drug approval
- Xphozah® (tenapanor) – New drug approval
- Zilbrysq® (zilucoplan) – New orphan drug approval
- Zituvio™ (sitagliptin) – New drug approval
- Zymfentra™ (infliximab-dyyb) – New drug approval
- Votrient® (pazopanib) – First-time generic
- Enbrel® (etanercept) – New indication
- Voxzogo® (vosoritide) – Expanded indication
- Penbraya™ (meningococcal groups A, B, C, W, and Y vaccine) – New vaccine approval
- Exela Pharma Sciences – Recall of sodium bicarbonate, midazolam, and ELCYS (cysteine hydrochloride) injection products
- Agamree® (vamorolone) – New orphan drug approval
- Cabtreo™ (clindamycin phosphate/adapalene/benzoyl peroxide) – New drug approval
- Loqtorzi™ (toripalimab-tpzi) – New orphan drug approval
- Omvoh™ (mirikizumab-mrkz) – New drug approval
- Rozlytrek® (entrectinib) – Expanded indication, new formulation approval
- Orencia® (abatacept) – Expanded indication
- Tibsovo® (ivosidenib) – New indication
- Vabysmo® (faricimab-svoa) – New indication
- Shortage of recently approved Beyfortus™ (nirsevimab-alip) due to high demand
- Recall of over-the-counter (OTC) eye drops
- Flovent Diskus® (fluticasone propionate) – First-time authorized brand alternative
- Voquezna® (vonoprazan) – New drug approval
- Wezlana™ (ustekinumab-auub) – New first-time interchangeable biosimilar approval
- Zituvimet (sitagliptin/metformin) – New drug approval
- Zepbound™ (tirzepatide) for weight loss – New drug approval
- Carospir® (spironolactone) – First-time generic
- Livalo® (pitavastatin) – First-time generic
- Cosentyx® (secukinumab) – New indication
- Keytruda® (pembrolizumab) – New indication
- Bayer announces decision to withdraw Aliqopa® (copanlisib)
- Recall of over-the-counter (OTC) eye drops
- Adzynma (ADAMTS13, recombinant-krhn) – New orphan drug approval
- Fruzaqla™ (fruquintinib) – New drug approval
- Ixchiq® (chikungunya vaccine, live) – New vaccine approval
- Keytruda® (pembrolizumab) – Updated indication
- RxHighlights - October 2023 Edition
- Novo Nordisk announces decision to discontinue Levemir® (insulin detemir)
- Augtyro™ (repotrectinib) – New orphan drug approval
- Ryzneuta® (efbemalenograstim alfa-vuxw) – New drug approval
- Truqap™ (capivasertib) – New drug approval
- Forteo® (teriparatide) – First-time generic
- Keytruda® (pembrolizumab) – Expanded indication
- Xtandi® (enzalutamide) – Expanded indication
- RxOutlook - 4th Quarter 2023
- Baxter – Recall of ondansetron injection
- Novartis – Recall of Sandimmune® (cyclosporine) oral solution
- Insight Pharmaceuticals – Recall of Ting® (miconazole nitrate) spray
- Unomedical A/S – Recall of VariSoft Infusion Set
- Ogsiveo™ (nirogacestat) – New orphan drug approval
- Alvaiz™ (eltrombopag) – New drug approval
- CAR T cell therapy– FDA safety update
- Levetiracetam (Keppra®, Keppra XR®, Elepsia™ XR, Spritam®) and clobazam (Onfi®, Sympazan™) – FDA drug safety communication
- Jaypirca® (pirtobrutinib) – New indication
- Wilate (von Willebrand factor/coagulation factor VIII complex [human]) – Expanded indication
- InvaGen Pharmaceuticals – Recall of vigabatrin oral solution
- Avzivi® (bevacizumab-tnjn) – New biosimilar approval
- Casgevy™ (exagamglogene autotemcel) and Lyfgenia® (lovotibeglogene autotemcel) – New orphan drug approvals
- Fabhalta® (iptacopan) – New drug approval
- Risperdal Consta® (risperidone) – First-time generic
- Cresemba® (isavuconazonium) – Expanded indication
- RxHighlights - November 2023 Edition
- Alyglo™ (immune globulin intravenous, human-stwk) – New drug approval
- Filsuvez® (birch triterpenes) – New orphan drug approval
- iDose® TR (travoprost intracameral implant) – New drug approval
- Iwilfin™ (eflornithine) – New orphan drug approval
- Zoryve® (roflumilast) – New formulation approval
- Condylox® (podofilox) – First-time generic
- Adbry® (tralokinumab-ldrm) – Expanded indication
- Bivigam® (immune globulin intravenous [human]) – Expanded indication
- Keytruda® (pembrolizumab) plus Padcev® (enfortumab vedotin-ejfv) – Expanded indication, accelerated approval converted to full approval
- Welireg® (belzutifan) – New indication
- Wainua™ (eplontersen) – New orphan drug approval
- Tarpeyo® (budesonide) – Updated indication, accelerated approval converted to full approval
- Carvykti® (ciltacabtagene autoleucel) – Boxed warning added
- Hospira – Recall of sodium bicarbonate and atropine injection products
- Hospira – Recall of bleomycin injection
- Insight – Recall of Americaine® 20% Benzocaine Topical Anesthetic Spray
- Reckitt/Mead Johnson Nutrition – Recall of Nutramigen™ Powder
- Udenyca® Onbody™ (pegfilgrastim-cbqv) – New biosimilar approval
- Zelsuvmi™ (berdazimer) – New drug approval
- Nascobal® (cyanocobalamin) – First-time generic
- Prolensa® (bromfenac) – First-time generic
- Farxiga® (dapagliflozin) – First-time authorized brand alternative
- Xigduo® XR (dapagliflozin/metformin) – First-time authorized brand alternative
- RxHighlights - December 2023 Edition
- FDA authorizes foreign importation of Bicillin® L-A (penicillin G benzathine)
- Hyqvia® (immune globulin infusion 10% [human] with recombinant human hyaluronidase) – New orphan indication
- FDA evaluates reports of suicidal thoughts or actions in patients taking glucagon-like peptide-1 receptor agonists (GLP-1 RAs)
- Keytruda® (pembrolizumab) – Expanded indication
- Indocin® (indomethacin) – First-time generic
- Korlym® (mifepristone) – First-time generic
- FDA safety update – Prolia® (denosumab)
- Balversa® (erdafitinib) – Updated indication, accelerated approval converted to full approval
- Casgevy™ (exagamglogene autotemcel) – New orphan indication
- Piqray® (alpelisib) – Expanded indication
- Dupixent® (dupilumab) – Expanded indication
- Keytruda® (pembrolizumab) – Updated indication, accelerated approval converted to full approval
- Azurity – Recall of Zenzedi® (dextroamphetamine)
- Haleon – Recall of Robitussin® Honey CF Max products
- Takeda – Withdrawal of Vonvendi® (von Willebrand factor, recombinant)
- Gralise® (gabapentin) – First-time generic
- Avycaz® (ceftazidime/avibactam) – Expanded indications
- Gammagard Liquid® (immune globulin infusion [human] 10% solution) – New indication
- RxOutlook - 1st Quarter 2024
- Eohilia™ (budesonide) – New orphan drug approval
- Alrex® (loteprednol) – First-time generic
- BromSite® (bromfenac) – First-time generic
- Emflaza® (deflazacort) – First-time generic
- RxHighlights - January 2024 Edition
- Amtagvi™ (lifileucel) – New orphan drug approval
- Aurlumyn™ (iloprost) – New orphan drug approval
- Onivyde® (irinotecan liposome injection) – New indication
- Tagrisso® (osimertinib) – Expanded indication
- Xolair® (omalizumab) – New indication
- Brassica Pharma – Recall of eye ointment products
- Exblifep® (cefepime/enmetazobactam) – New drug approval
- Simlandi® (adalimumab-ryvk) – New biosimilar approval
- Udenyca® Onbody™ (pegfilgrastim-cbqv) – First-time biosimilar launch
- Rectiv® (nitroglycerin) – First-time generic
- Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide) – Expanded indication
- Pfizer/BioNTech, Moderna, and Novavax COVID-19 vaccines (Omicron variant XBB.1.5) – CDC recommends an additional vaccine dose in 65 years and older
- Jubbonti® (denosumab-bbdz) – New first-time interchangeable biosimilar approval
- Letybo (letibotulinumtoxinA-wlbg) – New drug approval
- Wyost® (denosumab-bbdz) – New first-time interchangeable biosimilar approval
- Xofluza® (baloxavir marboxil) – Expanded indication
- Rybrevant® (amivantamab-vmjw) – New indication, accelerated approval converted to full approval
- Veklury® (remdesivir) – Expanded indication
- B. Braun Medical– Recall of potassium chloride for injection
- Clobetasol propionate ophthalmic suspension – New drug approval
- Tyenne® (tocilizumab-aazg) – New biosimilar approval
- Thiola EC® (tiopronin) – First-time generic
- Brukinsa® (zanubrutinib) – New indication
- Opdivo® (nivolumab) – New indication
- Wegovy® (semaglutide) – New indication
- RxHighlights - February 2024 Edition
- Praluent® (alirocumab) – Expanded indication
- Rezdiffra™ (resmetirom) – New drug approval
- Par Pharmaceutical – Recall of treprostinil injection
- Edurant ® (rilpivirine) – Expanded indication and new formulation
- Lenmeldy™ (atidarsagene autotemcel) – New orphan drug approval
- Tevimbra® (tislelizumab-jsgr) – New drug approval
- Besponsa™ (inotuzumab ozogamicin) – Updated indication
- Breyanzi® (lisocabtagene maraleucel) – New indication
- Iclusig® (ponatinib) – Expanded indication
- Livmarli® (maralixibat) – New indication
- Xhance® (fluticasone propionate) – New indication
- Spevigo® (spesolimab-sbzo) – Expanded indication
- Tryvio™ (aprocitentan) – New drug approval
- Duvyzat™ (givinostat) – New orphan drug approval
- Opsynvi® (macitentan/tadalafil) – New orphan drug approval
- Nexletol® (bempedoic acid), Nexlizet® (bempedoic acid/ezetimibe) – New/expanded indications
- Pemgarda™ (pemivibart) – Emergency use authorization approval
- Ultomiris® (ravulizumab-cwvz) – New indication
- Winrevair™ (sotatercept) – New orphan drug approval
- Amneal – Recall of vancomycin oral solution
- Eugia – Recall of methocarbamol injection
- AvKARE– Recall of atovaquone oral suspension
- Vafseo® (vadadustat) – New drug approval
- Voydeya™ (danicopan) – New orphan drug approval
- Ixinity® (coagulation factor IX [recombinant]) – Expanded indication
- Vemlidy® (tenofovir alafenamide) – New indication
- Relyvrio® (sodium phenylbutyrate/taurursodiol) – Drug discontinuation
- Risvan® (risperidone) – New drug approval
- Zevtera (ceftobiprole medocaril sodium) – New drug approval
- Abecma® (idecabtagene vicleucel) – Expanded indication
- Carvykti® (ciltacabtagene autoleucel) – Expanded indication
- Dovato (dolutegravir/lamivudine) – Expanded indication
- Enhertu® (fam-trastuzumab deruxtecan-nxki) – New indication
- Fanapt® (iloperidone) – New indication
- XGen Pharmaceuticals – Recall of cyclophosphamide injection
- Tyenne® (tocilizumab-aazg) – First-time biosimilar launch
- Fasenra® (benralizumab) – Expanded indication
- RxHighlights - March 2024 Edition
- Dr. Reddy’s – Recall of sapropterin powder for oral solution
- Anktiva® (nogapendekin alfa inbakicept-pmln) – New drug approval
- Entresto® Sprinkle (sacubitril/valsartan) – New formulation approval
- Retevmo® (selpercatinib) – New formulation approval
- Rezenopy (naloxone) – New drug approval
- Selarsdi™ (ustekinumab-aekn) – New biosimilar approval
- Xromi (hydroxyurea) – New drug approval
- Myrbetriq® (mirabegron) – First-time generic launch halted
- Alecensa® (alectinib) – New indication
- Entyvio® (vedolizumab) – New indication for subcutaneous use
- Beqvez™ (fidanacogene elaparvovec-dzkt) – New orphan drug approval
- Hercessi™ (trastuzumab-strf) – New biosimilar approval
- Libervant™ (diazepam) – New drug approval
- Ojemda™ (tovorafenib) – New orphan drug approval
- Pivya™ (pivmecillinam) – New drug approval
- Rinvoq® (upadacitinib), Rinvoq LQ (upadacitinib) – New formulation approval, New/expanded indications
- Vijoice® (alpelisib) – New formulation approval
- Xolremdi™ (mavorixafor) – New orphan drug approval
- EstroGel® (estradiol) – First-time generic
- Lutathera® (lutetium Lu 177 dotatate) – Expanded indication
- Otezla® (apremilast) – Expanded indication
- EpiHealth declares bankruptcy – Recalls Cloderm® (clocortolone pivalate) and Minolira™ (minocycline)
- Cyltezo® (adalimumab-adbm) – Correction - high concentration formulation approved as biosimilar, not interchangeable
- Ingrezza® Sprinkle (valbenazine) – New formulation approval
- Myhibbin (mycophenolate mofetil) – New drug approval
- Mircera® (methoxy polyethylene glycol-epoetin beta) – Expanded indication
- RxHighlights - April 2024 Edition
- Simlandi® (adalimumab-ryvk) – New biosimilar launch
- Breyanzi® (lisocabtagene maraleucel) – New indication
- Imdelltra™ (tarlatamab-dlle) – New drug approval
- Halaven® (eribulin) – First-time generic
- Opuviz™ (aflibercept-yszy) and Yesafili™ (aflibercept-jbvf)– New first-time interchangeable biosimilar approvals
- RxOutlook - 2nd Quarter 2024
- Hospira – Recall of buprenorphine injection and labetalol injection
- Bkemv™ (eculizumab-aeeb) – New first-time interchangeable biosimilar approval
- COVID-19 vaccines – VRBPAC makes recommendations for new monovalent vaccine composition
- Retevmo® (selpercatinib) – Expanded indications
- Breyanzi® (lisocabtagene maraleucel) – New indication
- mRESVIA™ (respiratory syncytial virus vaccine) – New vaccine approval
- Onyda™ XR (clonidine) – New drug approval
- Sagent – Recall of docetaxel injection
- RxHighlights - May 2024 Edition
- Arexvy® (respiratory syncytial virus vaccine) – Expanded indication
- Firdapse® (amifampridine) – Updated dosing
- Motpoly XR™ (lacosamide) – New indication
- Iqirvo® (elafibranor) – New orphan drug approval
- Rytelo™ (imetelstat) – New orphan drug approval
- Roche – Recall of Accu-Chek® Guide Meter
- Augtyro™ (repotrectinib) – New indication
- Blincyto® (blinatumomab) – New indication
- COVID-19 vaccines – FDA makes recommendations for new monovalent vaccine composition for 2024-2025
- Farxiga® (dapagliflozin), Xigduo® XR (dapagliflozin/metformin) – Expanded indication
- Imfinzi® (durvalumab) – New indication
- Kevzara® (sarilumab) – New indication
- Keytruda® (pembrolizumab) – New indication
- Capvaxive™ (pneumococcal 21-valent conjugate vaccine) – New vaccine approval
- Yimmugo® (immune globulin intravenous, human - dira) – New drug approval
- GLP-1 receptor agonist update – Tirzepatide for obstructive sleep apnea
- Krazati® (adagrasib) – New indication
- Skyrizi® (risankizumab-rzaa) – New indication
- Victoza® (liraglutide) – First-time authorized brand alternative
- Vyvgart® Hytrulo (efgartigimod alfa/hyaluronidase-qvfc) – New indication
- Wakix® (pitolisant) – Expanded indication
- Elevidys® (delandistrogene moxeparvovec-rokl) – Accelerated approval converted to traditional approval, expanded indication
- Piasky (crovalimab-akkz) – New orphan drug approval
- Sofdra™ (sofpironium) – New drug approval
- Vigafyde™ (vigabatrin) – New orphan drug approval
- Glenmark – Recall of potassium chloride extended-release capsules
- Somatuline® Depot (lanreotide) – First-time generic
- American Health Packaging – Recall of potassium chloride extended-release capsules
- Kisunla™ (donanemab-azbt) – New drug approval
- COVID-19 vaccines – ACIP makes recommendations for 2024-2025 vaccine administration
- Epkinly® (epcoritamab-bysp) – New indication
- RSV vaccines – CDC updates RSV vaccination recommendations
- Ahzantive™ (aflibercept-mrbb) – New biosimilar approval
- Chewtadzy (tadalafil) – New drug approval
- Nypozi™ (filgrastim-txid) – New biosimilar approval
- Ohtuvayre™ (ensifentrine) – New drug approval
- Pyzchiva® (ustekinumab-ttwe) – New biosimilar approval
- Velphoro® (sucroferric oxyhydroxide) – Expanded indication
- Zoryve® (roflumilast) – New indication, new strength
- Endo – Recall of clonazepam orally disintegrating tablets
- RxHighlights - June 2024 Edition
- Endari™ (l-glutamine) – First-time generic
- Voquezna® (vonoprazan) – New indication
- Epysqli® (eculizumab-aagh) – New biosimilar approval
- Tyenne® (tocilizumab-aazg) – New biosimilar formulation launch
- Hikma – Recall of acetaminophen injection
- Endo – Expanded recall of clonazepam orally disintegrating tablets (ODT)
- Livmarli® (maralixibat) – Expanded indication, new strength
- Kisqali® (ribociclib) – Updated indication
- Palforzia® (peanut [Arachis hypogaea] allergen powder-dnfp) – Expanded indication
- Erzofri®™ (paliperidone palmitate) – New drug approval
- Leqselvi™ (deuruxolitinib) – New drug approval
- Tezruly™ (terazosin) – New formulation approval
- Zunveyl® (benzgalantamine) – New drug approval
- B. Braun Medical – Recall of sodium chloride injection
- Darzalex Faspro® (daratumumab/hyaluronidase-fihj) – New indication
- Fibryga® (fibrinogen [human]) – New indication
- Jemperli (dostarlimab-gxly) – Expanded indication
- Brineura® (cerliponase alfa) – Expanded indication
- Tecelra® (afamitresgene autoleucel) – New orphan drug approval
- Abbott– Recall FreeStyle Libre® 3 Sensors
- Baxter – Recall of heparin sodium injection
- Corlanor® (ivabradine) – First-time generic
- Fabhalta® (iptacopan) – New indication
- Furoscix® (furosemide) – Expanded indication
- Crexont® (carbidopa/levodopa) – New drug approval
- Enzeevu™ (aflibercept-abzv) – New biosimilar approval
- Lymphir™ (denileukin diftitox-cxdl) – New orphan drug approval
- neffy® (epinephrine) – New drug approval
- Nemluvio® (nemolizumab-ilto) – New drug approval
- Voranigo® (vorasidenib) – New orphan drug approval
- Zurnai™ (nalmefene) – New drug approval
- Yorvipath® (palopegteriparatide) – New orphan drug approval
- RxHighlights - July 2024 Edition
- Imfinzi® (durvalumab) – New indication
- Nexobrid® (anacaulase-bcdb) – Expanded indication
- Protonix® I.V. (pantoprazole) – Expanded indication
- Livdelzi® (seladelpar) – New orphan drug approval
- Niktimvo™ (axatilimab-csfr) – New orphan drug approval
- Comirnaty® and Spikevax® (KP.2) 2024 – 2025 vaccines – FDA approval and Emergency Use Authorization
- Lazcluze™ (lazertinib) – New drug approval, Rybrevant® (amivantamab) – New indication
- Lucemyra® (lofexidine) – First-time generic
- RxOutlook - 3rd Quarter 2024
- ACAM2000™ (smallpox and mpox (vaccinia) vaccine, live) – New indication
- Novavax COVID-19 vaccine, adjuvanted (2024-2025 formula) – Emergency Use Authorization
- Prevymis® (letermovir) – Expanded indication, new dosage formulation
- Pavblu™ (aflibercept-ayyh) – New biosimilar approval
- Oxtellar XR® (oxcarbazepine) – First-time generic
- Sprycel® (dasatinib) – First-time generic
- RxHighlights - August 2024 Edition
- Filspari® (sparsentan) – Updated indication, accelerated approval converted to full approval
- Dupixent® (dupilumab) – Expanded indication
- Tremfya® (guselkumab) – New indication
- Ebglyss™ (lebrikizumab-lbkz) – New drug approval
- Ocrevus Zunovo™ (ocrelizumab/hyaluronidase-ocsq) – New subcutaneous formulation approval
- Tecentriq Hybreza™ (atezolizumab/hyaluronidase-tqjs) – New subcutaneous formulation approval
- Bionpharma – Recall of atovaquone oral suspension
- Sarclisa® (isatuximab-irfc) – New indication
- Bimzelx® (bimekizumab) – New indications
- Cimzia® (certolizumab pegol) – New indication
- Fasenra® (benralizumab) – New indication
- Keytruda® (pembrolizumab) – New indication
- Kisqali® (ribociclib) – New indication
- Rybrevant® (amivantamab-vmjw) – New indication
- FluMist® (influenza vaccine live) – Self-administration approval
- Miplyffa™ (arimoclomol) – New orphan drug approval
- Gilead – Recall of Veklury® (remdesivir) injection
- Pfizer – Withdrawal of Oxbryta® (voxelotor) tablets
- Dupixent® (dupilumab) for COPD – New indication approval
- Tagrisso® (osimertinib) – New indication
- Aqneursa™ (levacetylleucine) – New drug approval
- Cobenfy™ (xanomeline and trospium hydrochloride) – New drug approval
- Otulfi™ (ustekinumab-aauz) – New biosimilar approval
- Sandostatin® LAR Depot (octreotide) – First-time generic
- Opdivo® (nivolumab) – New indication
- RxHighlights - September 2024 Edition
- Bimzelx® (bimekizumab-bkzx) – New device approvals
- Hympavzi™ (marstacimab-hncq) – New orphan drug approval
- Imuldosa™ (ustekinumab-srlf) – New biosimilar approval
- Itovebi™ (inavolisib) – New drug approval
- Lumryz™ (sodium oxybate) – Expanded indication
- Selarsdi™ (ustekinumab-aekn) – New indications and formulation approval
- Trodelvy™ (sacituzumab govitecan-hziy) – Indication withdrawal
- Vyalev™ (foscarbidopa/foslevodopa) – New drug approval
- Vyloy® (zolbetuximab-clzb) – New orphan drug approval
- Medtronic – Recall of MiniMed™ 600 series or 700 series insulin pumps
- Abrysvo® (respiratory syncytial virus vaccine) – New indication
- COVID-19 vaccines – ACIP recommends additional 2024-2025 vaccine doses for certain groups
- Orlynvah™ (sulopenem etzadroxil/probenecid) – New drug approval
- Scemblix® (asciminib) – New indication
- PreHevBrio® (hepatitis B vaccine [recombinant]) – Discontinuation and withdrawal from the market
- Stendra® (avanafil) – First-time generic
- Aucatzyl® (obecabtagene autoleucel) – New orphan drug approval
- Danziten (nilotinib) – New drug approval
- Emrosi™ (minocycline) – New drug approval
- Pavblu™ (aflibercept-ayyh) – New biosimilar launch
- Mitsubishi Tanabe – Discontinuation of Radicava® (edaravone) intravenous
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