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

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Summary

FDA approves Vertex's supplemental application for KALYDECO (ivacaftor), resulting in updated labeling for additional cystic fibrosis indications.

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Diseases / indications

• Cystic Fibrosis

Drugs mentioned

• Kalydeco (ivacaftor)

Snippet

SUPPL AP for KALYDECO (IVACAFTOR)