Treats partial-onset seizures. ANDA 220385, held by Regcon Holdings. Brivaracetam.
As of Nov 15, 2026, ANDA 220385 (Brivaracetam), held by Regcon Holdings, was first approved by FDA on Feb 23, 2026, with 0 approved supplements and 0 published complete response letters.
Brivaracetam oral solution 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 | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Brivaracetam10MG/ML · solution;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
