FDA — authorised 5 May 2014
- Application: NDA205060
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: EPANOVA
- Indication: CAPSULE — ORAL
- Status: approved
FDA authorised omefas on 5 May 2014
Yes. FDA authorised it on 5 May 2014.
ASTRAZENECA holds the US marketing authorisation.