FDA
approval
· 2024-03-22
FDA Approved: OPSYNVI — Original Application (Actelion Pharmaceuticals US, Inc.)
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
Snippet
ORIG AP for OPSYNVI (MACITENTAN AND TADALAFIL)