Catalyst Wire Dossier Catalyst Wire Dossier
FDA label_change · 2015-04-30

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

View source ↗

Summary

FDA approved a supplemental application for OPSUMIT (macitentan) submitted by Actelion Pharmaceuticals US, Inc., resulting in updated labeling for the drug used…

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

Diseases / indications

Drugs mentioned

  • OPSUMIT (macitentan)

Snippet

SUPPL AP for OPSUMIT (MACITENTAN)