Chemical Namelumacaftor/ivacaftor
Dosage FormTablet (oral; lumacaftor mg/ivacaftor mg: 100 mg/125 mg, 200 mg/125 mg); granules (oral; lumacaftor mg/ivacaftor mg: 100 mg/125 mg, 150 mg/188 mg)
Drug ClassCFTR potentiators
CompanyVertex Pharms Inc
Approval Year2015


  • For the treatment of cystic fibrosis (CF) in patients age 2 years and older who are homozygous for the F508del mutation in the CFTR gene.
Last updated on 10/29/2020

More on this drug: Clinical Trials

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Document TitleYearSource
Orkambi (lumacaftor and ivacaftor) Prescribing Information2019Vertex Pharmaceuticals Incorporated, Boston, MA