Symdeko Approval History
FDA Approved: Yes (First approved February 12, 2018)
Brand name: Symdeko
Generic name: ivacaftor/tezacaftor and ivacaftor
Dosage form: Tablets
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis
Symdeko (ivacaftor/tezacaftor tablets and ivacaftor tablets) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator and CFTR corrector combination for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have two copies of the F508del mutation, or who have at least one mutation in the CF gene that is responsive to treatment with Symdeko.
Development History and FDA Approval Process for Symdeko
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