Treats pulmonary arterial hypertension (PAH, WHO Group I). NDA 218490, held by Actelion. Macitentan; Tadalafil.
As of Nov 14, 2026, NDA 218490 (Opsynvi), held by Actelion, was first approved by FDA on Mar 22, 2024, with 2 approved supplements and 0 published complete response letters.
OPSYNVI is a combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, indicated for chronic treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients of WHO functional class (FC) II–III. Individually, macitentan reduces the risk of clinical worsening events and hospitalization, and tadalafil improves exercise ability. ( 1.1, 14 ) 1.1 Pulmonary Arterial Hypertension OPSYNVI is the combination of macitentan and tadalafil indicated for the chronic treatment of adults with pulmonary arterial hypertension (PAH, WHO Group I and WHO Functional Class (FC) II–III).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 22, 2024 | Original applicationNew combination · Standard review | Approved |
| Opsynvi10MG;20MG · tablet;oral | Macitentan; Tadalafil | RxReference drug |
| Opsynvi10MG;40MG · tablet;oral | Macitentan; Tadalafil | RxReference drug |
| Apr 2, 2025 | Supplement 2REMS | Approved | |
| Dec 12, 2024 | Supplement 1REMS | Approved | |
| Mar 22, 2024 | Original applicationNew combination · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
