Treats pulmonary arterial hypertension (PAH) (WHO Group 1). ANDA 213981, held by Zydus Pharms. Bosentan.
As of Nov 14, 2026, ANDA 213981 (Bosentan), held by Zydus Pharms, was first approved by FDA on Feb 17, 2026, with 2 approved supplements and 0 published complete response letters.
Bosentan tablets for oral suspension are 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 17, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bosentan32MG · tablet, for suspension;oral | Bosentan | Rx |
| Oct 27, 2026 | Supplement 2REMS | Approved | None posted |
| Mar 3, 2026 | Supplement 1REMS | Approved | None posted |
| Feb 17, 2026 | Original application | Approved | None posted |
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
