Treats partial-onset seizures. ANDA 220288, held by Aurobindo Pharma. Brivaracetam.
As of Nov 15, 2026, ANDA 220288 (Brivaracetam), held by Aurobindo Pharma, was first approved by FDA on Aug 10, 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 |
|---|---|---|---|
| Aug 10, 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
