Treats pulmonary arterial hypertension (PAH, WHO Group I). ANDA 211026, held by Lepu Pharm. Macitentan.
As of Nov 13, 2026, ANDA 211026 (Macitentan), held by Lepu Pharm, was first approved by FDA on Dec 3, 2025, with 1 approved supplement and 0 published complete response letters.
Macitentan is an 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 |
|---|---|---|---|
| Dec 3, 2025 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Macitentan10MG · tablet;oral | Macitentan | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 19, 2026 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 3, 2025 | Original application | Approved |
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
