FDA — authorised 18 November 2020
- Application: BLA761069
- Marketing authorisation holder: ASTRAZENECA UK LTD
- Indication: Labeling
- Status: approved
🇺🇸 Imfinzi in United States
FDA authorised Imfinzi on 18 November 2020
Marketing authorisation
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 18 November 2020.
Who is the marketing authorisation holder for Imfinzi in United States?
ASTRAZENECA UK LTD holds the US marketing authorisation.