Treats pulmonary arterial hypertension (PAH) (WHO Group 1). ANDA 213154, held by Natco Pharma Ltd. Bosentan.
As of Nov 14, 2026, ANDA 213154 (Bosentan), held by Natco Pharma Ltd, was first approved by FDA on Feb 5, 2025, with 6 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE Bosentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%). in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 5, 2025 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bosentan32MG · tablet, for suspension;oral | Bosentan | Rx |
| Oct 27, 2026 | Supplement 8REMS | Approved | None posted |
| Jun 23, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 23, 2026 | Supplement 6Labeling · Standard review | Approved | None posted |
| Mar 3, 2026 | Supplement 7REMS | Approved | None posted |
| Nov 5, 2025 | Supplement 4REMS | Approved | None posted |
| Feb 21, 2025 | Supplement 2REMS | Approved | None posted |
| Feb 5, 2025 | Original application | 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
