Treats partial-onset seizures. NDA 205836, held by Ucb Inc. Brivaracetam.
As of Nov 13, 2026, NDA 205836 (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 9Efficacy (new indication or use) · Standard review | Approved | |
| May 10, 2018 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Sep 14, 2017 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Feb 18, 2016 | Original applicationNew molecular entity · Standard review | Approved |
| Briviact10MG · tablet;oral | Brivaracetam | RxReference drug |
| Briviact25MG · tablet;oral | Brivaracetam | RxReference drug |
| Briviact50MG · tablet;oral | Brivaracetam | RxReference drug |
| Briviact75MG · tablet;oral | Brivaracetam | RxReference drug |
| Briviact100MG · tablet;oral | Brivaracetam | RxReference drug |
| Aug 28, 2025 | Supplement 17Labeling · Standard review | Approved | |
| May 17, 2023 | Supplement 14Labeling · Standard review | Approved | |
| Sep 2, 2021 | Supplement 11Labeling · Standard review | Approved | |
| Aug 27, 2021 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| May 10, 2018 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Sep 14, 2017 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jun 3, 2016 | Supplement 1Labeling · Standard review | Approved | |
| Feb 18, 2016 | Original applicationNew molecular entity · 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
