Treats pulmonary arterial hypertension (PAH, WHO Group I). ANDA 211195, held by Apotex. Macitentan.
As of Nov 13, 2026, ANDA 211195 (Macitentan), held by Apotex, was first approved by FDA on Jan 9, 2024, with 3 approved supplements and 0 published complete response letters.
Macitentan tablets are 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 |
|---|---|---|---|
| Jan 9, 2024 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Macitentan10MG · tablet;oral | Macitentan | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 2, 2025 | Supplement 3REMS | Approved | None posted |
| Dec 12, 2024 | Supplement 2REMS | Approved | None posted |
| Apr 11, 2024 | Supplement 1REMS | Approved | None posted |
| Jan 9, 2024 | 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
