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FDA approval · 2012-01-31

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

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Summary

The FDA approved KALYDECO (ivacaftor) through an original application for the treatment of cystic fibrosis in patients with specific CFTR gating mutations.

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Diseases / indications

Drugs mentioned

  • Kalydeco (ivacaftor)

Snippet

ORIG AP for KALYDECO (IVACAFTOR)