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FDA approval · 2025-02-28

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

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Summary

FDA approved a supplemental application for OPSUMIT (macitentan) submitted by Actelion Pharmaceuticals US, Inc. The approval involves changes to the product lab…

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Diseases / indications

Drugs mentioned

  • OPSUMIT (macitentan)

Snippet

SUPPL AP for OPSUMIT (MACITENTAN)