Kalydeco

Vertex Pharmaceuticals Incorporated🇺🇸 United States

FDA Page

Effective Date: Mar 23, 2026
Approval ID: 0ab0c9f8-3eee-4e0f-9f3f-c1e16aaffe25
Products: 6 registered
Version: 36

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use KALYDECO safely and effectively. See full prescribing information for KALYDECO. KALYDECO (ivacaftor) tablets, for oral useKALYDECO (ivacaftor) oral granulesInitial U.S. Approval: 2012

Quick Stats

Total Products6

Labelers2

Label Sections25

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.