Kalydeco® (ivacaftor) – Expanded indication and new dosage strengths
May 3, 2023 - Vertex Pharmaceuticals announced the FDA approval of Kalydeco (ivacaftor), for the treatment of cystic fibrosis (CF) in patients age 1 month and older who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data.
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