FDA — authorised 12 February 2004
- Application: BLA125084
- Marketing authorisation holder: IMCLONE
- Local brand name: ERBITUX
- Indication: VIAL — INTRAVENOUS
- Status: approved
FDA authorised Cetuximab injection on 12 February 2004
Yes. FDA authorised it on 12 February 2004.
IMCLONE holds the US marketing authorisation.