Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2025-04-02

FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)

View source ↗

Summary

The FDA approved a supplemental application for OPSUMIT (macitentan) filed by Actelion Pharmaceuticals US, Inc., resulting in approved changes to the drug's lab…

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

Diseases / indications

Drugs mentioned

  • OPSUMIT (macitentan)

Snippet

SUPPL AP for OPSUMIT (MACITENTAN)