FDA — authorised 28 April 2020
- Application: NDA210296
- Marketing authorisation holder: BANNER LIFE SCIENCES
- Local brand name: BAFIERTAM
- Indication: CAPSULE, DELAYED RELEASE — ORAL
- Status: approved
FDA authorised Bafiertam on 28 April 2020
Yes. FDA authorised it on 28 April 2020.
BANNER LIFE SCIENCES holds the US marketing authorisation.