Treats pulmonary arterial hypertension (PAH, WHO Group I). ANDA 211120, held by Laurus. Macitentan.
As of Nov 13, 2026, ANDA 211120 (Macitentan), held by Laurus, was first approved by FDA on Nov 5, 2025, with 0 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 |
|---|---|---|---|
| Nov 5, 2025 | Original application | Approved | None posted |
| 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
