Treats pulmonary arterial hypertension (PAH, WHO Group I). ANDA 214302, held by Zydus Lifesciences. Selexipag.
As of Nov 14, 2026, ANDA 214302 (Selexipag), held by Zydus Lifesciences, was first approved by FDA on Dec 21, 2022, with 0 approved supplements and 0 published complete response letters.
Selexipag tablets are a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I): In adults to delay disease progression and reduce the risk of hospitalization for PAH. 1.1 Pulmonary Arterial Hypertension Adult Patients
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 21, 2022 | Original application | Approved |
| Selexipag0.2MG · tablet;oral | Selexipag | Discontinued |
| Selexipag0.4MG · tablet;oral | Selexipag | Discontinued |
| Selexipag0.6MG · tablet;oral | Selexipag | Discontinued |
| Selexipag0.8MG · tablet;oral | Selexipag | Discontinued |
| Selexipag1MG · tablet;oral | Selexipag | Discontinued |
| Selexipag1.2MG · tablet;oral | Selexipag | Discontinued |
| Selexipag1.4MG · tablet;oral | Selexipag | Discontinued |
| Selexipag1.6MG · tablet;oral | Selexipag | Discontinued |
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
