FDA — authorised 9 June 2022
- Application: ANDA214748
- Marketing authorisation holder: SUNSHINE
- Local brand name: BRIVARACETAM
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Briviact in United States
FDA authorised Briviact on 9 June 2022
Marketing authorisations
FDA — authorised 3 October 2022
- Application: ANDA214501
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: BRIVARACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 December 2022
- Application: ANDA214918
- Marketing authorisation holder: LUPIN
- Local brand name: BRIVARACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 January 2023
- Application: ANDA214848
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: BRIVARACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 November 2025
- Application: ANDA214921
- Marketing authorisation holder: MSN
- Local brand name: BRIVARACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 February 2026
- Application: ANDA214922
- Marketing authorisation holder: MSN
- Local brand name: BRIVARACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 23 February 2026
- Application: ANDA220385
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: BRIVARACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 23 February 2026
- Application: ANDA214924
- Marketing authorisation holder: MSN
- Local brand name: BRIVARACETAM
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 23 February 2026
- Application: ANDA218494
- Marketing authorisation holder: ZHEJIANG POLY PHARM
- Local brand name: BRIVARACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 23 February 2026
- Application: ANDA219772
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
FDA — authorised 23 February 2026
- Application: ANDA218249
- Marketing authorisation holder: HAINAN POLY
- Local brand name: BRIVARACETAM
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
The FDA approved Briviact (brivaracetam) injection for intravenous use on 23 February 2026. This approval was granted to Hainan Poly, the marketing authorisation holder. Briviact is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
FDA — authorised 23 February 2026
- Application: ANDA214875
- Marketing authorisation holder: APOTEX
- Local brand name: BRIVARACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 February 2026
- Application: ANDA214880
- Marketing authorisation holder: MICRO LABS
- Local brand name: BRIVARACETAM
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 23 February 2026
- Application: ANDA220470
- Marketing authorisation holder: CENTAUR PHARMS PVT
- Local brand name: BRIVARACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 February 2026
- Application: ANDA220164
- Marketing authorisation holder: LUPIN
- Local brand name: BRIVARACETAM
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA214831
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: BRIVARACETAM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA219583
- Marketing authorisation holder: SHANDONG NEW TIME PHARMACEUTICAL CO LTD
- Local brand name: BRIVARACETAM
- Indication: TABLET
- Status: approved
Briviact in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Briviact approved in United States?
Yes. FDA authorised it on 9 June 2022; FDA authorised it on 3 October 2022; FDA authorised it on 20 December 2022.
Who is the marketing authorisation holder for Briviact in United States?
SUNSHINE holds the US marketing authorisation.