FDA — authorised 6 April 2021
- Application: BLA125084
- Marketing authorisation holder: IMCLONE
- Indication: Efficacy
- Status: approved
FDA authorised Erbitux on 6 April 2021
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 6 April 2021.
IMCLONE holds the US marketing authorisation.