FDA — authorised 17 September 2001
- Application: BLA103951
- Marketing authorisation holder: AMGEN
- Local brand name: ARANESP
- Indication: VIAL — INTRAVENOUS
- Status: approved
FDA authorised Darbeopoetin on 17 September 2001
Yes. FDA authorised it on 17 September 2001.
AMGEN holds the US marketing authorisation.