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 |
|---|---|---|---|
| Apr 26, 2019 | Original application | Approved |
| Oct 27, 2026 | Supplement 21REMS | Approved | None posted |
| Apr 1, 2026 | Supplement 13Labeling · Standard review | Approved | None posted |
| Apr 1, 2026 | Supplement 18Labeling · Standard review | Approved | None posted |
| Apr 1, 2026 | Supplement 19Labeling · Standard review | Approved | None posted |
| Mar 3, 2026 | Supplement 20REMS | Approved | None posted |
| Nov 5, 2025 | Supplement 16REMS | Approved | None posted |
| Feb 21, 2025 | Supplement 14REMS | Approved | None posted |
| Sep 17, 2024 | Supplement 10REMS | Approved | None posted |
| Aug 19, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 19, 2024 | Supplement 9Labeling · Standard review | Approved | None posted |
| Apr 29, 2022 | Supplement 6REMS | Approved | None posted |
| Nov 1, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 26, 2019 | 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
