🇺🇸 Imfinzi in United States

FDA authorised Imfinzi on 1 May 2017

Marketing authorisations

FDA — authorised 1 May 2017

  • Application: BLA761069
  • Marketing authorisation holder: ASTRAZENECA UK LTD
  • Status: supplemented

FDA

  • Status: approved

Imfinzi in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in United States

Frequently asked questions

Is Imfinzi approved in United States?

Yes. FDA authorised it on 1 May 2017; FDA has authorised it.

Who is the marketing authorisation holder for Imfinzi in United States?

ASTRAZENECA UK LTD holds the US marketing authorisation.