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FDA approval · 2019-04-23

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

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Summary

FDA approves a supplemental application for OPSUMIT (macitentan) from Actelion Pharmaceuticals US, Inc., related to the existing macitentan NDA.

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Diseases / indications

Drugs mentioned

  • OPSUMIT (macitentan)

Snippet

SUPPL AP for OPSUMIT (MACITENTAN)