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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