FDA
approval
· 2024-12-12
FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
Summary
The FDA approved a supplemental application for OPSUMIT (macitentan) by Actelion Pharmaceuticals US, Inc., regarding an updated/expanded approval for its use.
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Diseases / indications
Drugs mentioned
Snippet
SUPPL AP for OPSUMIT (MACITENTAN)