FDA — authorised 23 February 2026
- Application: ANDA219772
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
🇺🇸 Brivaracetam oral solution in United States
FDA authorised Brivaracetam oral solution on 23 February 2026
Marketing authorisations
FDA — authorised 23 February 2026
- Application: ANDA220385
- Marketing authorisation holder: REGCON HOLDINGS
- Status: approved
FDA
- Status: approved
Brivaracetam oral solution in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Brivaracetam oral solution approved in United States?
Yes. FDA authorised it on 23 February 2026; FDA authorised it on 23 February 2026; FDA has authorised it.
Who is the marketing authorisation holder for Brivaracetam oral solution in United States?
ALKEM LABS LTD holds the US marketing authorisation.