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FDA approval · 2017-07-31

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

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Summary

The FDA entry concerns a supplemental application for KALYDECO (ivacaftor) submitted by Vertex Pharmaceuticals Incorporated, associated with NDA 207925.

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Diseases / indications

Drugs mentioned

  • Kalydeco (ivacaftor)

Snippet

SUPPL AP for KALYDECO (IVACAFTOR)