Kalydeco Approval History
- FDA approved: Yes (First approved January 31st, 2012)
- Brand name: Kalydeco
- Generic name: ivacaftor
- Dosage form: Tablets
- Company: Vertex Pharmaceuticals Incorporated
- Treatment for: Cystic Fibrosis
Kalydeco (ivacaftor) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 2 years and older who have the G551D or R117H mutations in the CFTR gene.
Development History and FDA Approval Process for Kalydeco
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