Treats partial-onset seizures. NDA 205838, held by Ucb Inc. Brivaracetam.
As of Nov 14, 2026, NDA 205838 (Briviact), held by Ucb Inc, was first approved by FDA on Feb 18, 2016, with 7 approved supplements and 0 published complete response letters.
BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.
| Aug 27, 2021 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| May 10, 2018 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Sep 14, 2017 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Feb 18, 2016 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Briviact10MG/ML · solution;oral | Brivaracetam | RxReference drug |
| Aug 28, 2025 | Supplement 15Labeling · Standard review | Approved | |
| May 17, 2023 | Supplement 11Labeling · Standard review | Approved | |
| Sep 2, 2021 | Supplement 8Labeling · Standard review | Approved | |
| Aug 27, 2021 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| May 10, 2018 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Sep 14, 2017 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jun 3, 2016 | Supplement 1Labeling · Standard review | Approved | |
| Feb 18, 2016 | Original applicationNew dosage form · Standard review | Approved |
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
