Treats pulmonary arterial hypertension (PAH, WHO Group I). ANDA 211123, held by Sun Pharm. Macitentan.
As of Nov 13, 2026, ANDA 211123 (Macitentan), held by Sun Pharm, was first approved by FDA on Aug 26, 2025, with 0 approved supplements and 0 published complete response letters.
Macitentan tablets are endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH. 1.1 Pulmonary Arterial Hypertension
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 26, 2025 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Macitentan10MG · tablet;oral | Macitentan | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
