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 in patients aged 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the CFTR) gene that is responsive to Symdeko.