FDA — authorised 23 September 2016
- Application: BLA761024
- Marketing authorisation holder: AMGEN INC
- Local brand name: AMJEVITA
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised ABP 501 on 23 September 2016
Yes. FDA authorised it on 23 September 2016.
AMGEN INC holds the US marketing authorisation.