elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets co-packaged for oral use Initial U.S. Approval: 2019
Facts about elexacaftor, tezacaftor, and ivacaftor tablets
Approval Date: 2019
Proprietary Name: On Request
Active Ingredient(s): elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets
Dosage Forms And Strengths:Fixed-dose combination containing elexacaftor 50 mg, tezacaftor 25 mg and ivacaftor 37.5 mg co-packaged with ivacaftor 75 mg.
Company: Vertex Pharmaceuticals
Disease: Cystic fibrosis
Medicine Approved By: – European Medical Agency (EMA), Food and Drug Administration (FDA), Health Canada, Therapeutic Goods Administration (TGA), Medsafe (NZ)
Summary of FDA approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
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Query For elexacaftor, tezacaftor, and ivacaftor tablets
Approved accessible "elexacaftor, tezacaftor, and ivacaftor tablets"
TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients ages 12 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 80,000 people globally. CF is a progressive, multi-system disease that affects the lungs, liver, GI tract, sinuses, sweat glands, pancreas and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene.
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TRIKAFTA (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets), co-packaged for oral use Initial U.S. Approval: 2019
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