FDA — authorised 21 August 2009
- Application: NDA020427
- Marketing authorisation holder: LUNDBECK PHARMS LLC
- Local brand name: SABRIL
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Vigabatrin Tablets on 21 August 2009
Yes. FDA authorised it on 21 August 2009.
LUNDBECK PHARMS LLC holds the US marketing authorisation.