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

View source ↗

Summary

The FDA approved a supplemental application for KALYDECO (ivacaftor) submitted by Vertex, resulting in changes to the drug's labeling.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

• Cystic Fibrosis

Drugs mentioned

• Kalydeco (ivacaftor)

Snippet

SUPPL AP for KALYDECO (IVACAFTOR)