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

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Summary

The FDA granted original approval of KALYDECO (ivacaftor) from Vertex Pharmaceuticals under NDA 207925. It is approved for the treatment of cystic fibrosis in p…

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Diseases / indications

• Cystic Fibrosis

Drugs mentioned

• Kalydeco (ivacaftor)

Snippet

ORIG AP for KALYDECO (IVACAFTOR)