Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2024-12-13

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

View source ↗

Summary

FDA approved a supplemental application for ORKAMBI (lumacaftor and ivacaftor) submitted by Vertex Pharmaceuticals. The action updates/expands the drug's labeli…

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

Diseases / indications

Drugs mentioned

  • ORKAMBI (lumacaftor and ivacaftor)

Snippet

SUPPL AP for ORKAMBI (LUMACAFTOR AND IVACAFTOR)