Trikafta

Vertex Pharmaceuticals Incorporated🇺🇸 United States

FDA Page

Effective Date: Jun 22, 2026
Approval ID: f354423a-85c2-41c3-a9db-0f3aee135d8d
Products: 4 registered
Version: 23

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use TRIKAFTA safely and effectively. See full prescribing information for TRIKAFTA. TRIKAFTA (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets), co-packaged for oral use TRIKAFTA (elexacaftor, tezacaftor, and ivacaftor oral granules; ivacaftor oral granules), co-packaged Initial U.S. Approval: 2019

Quick Stats

Total Products4

Labelers2

Label Sections41

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.