🇺🇸 Cetuximab injection in United States

FDA authorised Cetuximab injection on 12 February 2004

Marketing authorisation

FDA — authorised 12 February 2004

  • Application: BLA125084
  • Marketing authorisation holder: IMCLONE
  • Local brand name: ERBITUX
  • Indication: VIAL — INTRAVENOUS
  • Status: approved

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Other Oncology approved in United States

Frequently asked questions

Is Cetuximab injection approved in United States?

Yes. FDA authorised it on 12 February 2004.

Who is the marketing authorisation holder for Cetuximab injection in United States?

IMCLONE holds the US marketing authorisation.