Treats partial-onset seizures. ANDA 214921, held by Msn. Brivaracetam.
As of Nov 15, 2026, ANDA 214921 (Brivaracetam), held by Msn, was first approved by FDA on Nov 13, 2025, with 0 approved supplements and 0 published complete response letters.
Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 13, 2025 | Original application | Approved |
| Brivaracetam10MG · tablet;oral | Brivaracetam | Rx |
| Brivaracetam25MG · tablet;oral | Brivaracetam | Rx |
| Brivaracetam50MG · tablet;oral | Brivaracetam | Rx |
| Brivaracetam75MG · tablet;oral | Brivaracetam | Rx |
| Brivaracetam100MG · tablet;oral | Brivaracetam | Rx |
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
