ivacaftor
ivacaftor is listed in the FDA National Drug Code directory with 13 NDC codes, marketed under brand name including Kalydeco. Available dosage forms: granule, tablet, film coated, powder.
Drug Details
- Generic Name
- ivacaftor
- Brand Names
- Kalydeco
- Application Number
- NDA207925
- Sponsor
- Vertex Pharmaceuticals Incorporated
- NDC Codes
- 13
- Dosage Forms
- GRANULE, TABLET, FILM COATED, POWDER
- Routes
- ORAL
- Active Ingredients
- IVACAFTOR
Indications and Usage
1 INDICATIONS AND USAGE ORKAMBI is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene. ORKAMBI is a combination of ivacaftor, a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, and lumacaftor, indicated for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene. If the patient's genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene. ( 1 ) Limitations of Use: The efficacy and safety of ORKAMBI have not been established in patients with CF other than those homozygous for the F508del mutation. ( 1 ) Limitations of Use The efficacy and safety of ORKAMBI have not been established in patients with CF other than those homozygous for the F508del mutation .