FDA — authorised 30 September 2013
- Application: NDA204447
- Marketing authorisation holder: TAKEDA PHARMS USA
- Local brand name: TRINTELLIX
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Vortioxetine Hydrobromide Tablets on 30 September 2013
Yes. FDA authorised it on 30 September 2013.
TAKEDA PHARMS USA holds the US marketing authorisation.