FDA — authorised 12 September 2008
- Application: NDA022285
- Marketing authorisation holder: UCB INC
- Local brand name: KEPPRA XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA authorised Keppra XR (Levetiracetam XR) on 12 September 2008
Yes. FDA authorised it on 12 September 2008.
UCB INC holds the US marketing authorisation.