FDA — authorised 25 September 1998
- Application: BLA103792
- Marketing authorisation holder: GENENTECH
- Status: supplemented
🇺🇸 Herceptin in United States
FDA authorised Herceptin on 25 September 1998
Marketing authorisations
FDA — authorised 28 February 2019
- Application: BLA761106
- Marketing authorisation holder: GENENTECH INC
- Status: supplemented
FDA
- Status: approved
Other Oncology approved in United States
Frequently asked questions
Is Herceptin approved in United States?
Yes. FDA authorised it on 25 September 1998; FDA authorised it on 28 February 2019; FDA has authorised it.
Who is the marketing authorisation holder for Herceptin in United States?
GENENTECH holds the US marketing authorisation.