Treats partial-onset seizures. ANDA 214924, held by Msn. Brivaracetam.
As of Nov 15, 2026, ANDA 214924 (Brivaracetam), held by Msn, was first approved by FDA on Feb 23, 2026, with 0 approved supplements and 0 published complete response letters.
Brivaracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 23, 2026 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Brivaracetam50MG/5ML (10MG/ML) · solution;intravenous | 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
