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FDA approval · 2025-05-22

FDA Approved: KALYDECO — Supplemental Application (Vertex Pharmaceuticals Incorporated)

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Summary

The FDA approved Vertex's supplemental application for KALYDECO (ivacaftor), updating its labeling for use in cystic fibrosis.

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Diseases / indications

Drugs mentioned

  • Kalydeco (ivacaftor)

Snippet

SUPPL AP for KALYDECO (IVACAFTOR)