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FDA approval · 2024-03-22

FDA Approved: OPSYNVI — Original Application (Actelion Pharmaceuticals US, Inc.)

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Summary

FDA approved OPSYNVI, a fixed-dose combination of macitentan and tadalafil, under Original Application NDA218490 for pulmonary arterial hypertension.

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Diseases / indications

Drugs mentioned

  • OPSYNVI (MACITENTAN AND TADALAFIL)
  • TADALAFIL (TADALAFIL)

Snippet

ORIG AP for OPSYNVI (MACITENTAN AND TADALAFIL)