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Zevtera (ceftobiprole medocaril sodium) – New drug approval

April 3, 2024 - The FDA announced the approval of Basilea Pharmaceutica’s Zevtera (ceftobiprole medocaril sodium), for the treatment of Adult patients with Staphylococcus aureus bloodstream infection (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates; Adult patients with acute bacterial skin and skin structure infections caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, and Klebsiella pneumoniae; Adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Staphylococcus aureus (methicillin-susceptible isolates), Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Escherichia coli, and Klebsiella pneumoniae.

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