Symdeko FDA Approval History
Last updated by Judith Stewart, BPharm on July 2, 2019.
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.
Development Timeline for Symdeko
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