FDA — authorised 30 March 2009
- Application: NDA022334
- Marketing authorisation holder: NOVARTIS
- Status: supplemented
🇺🇸 Afinitor in United States
FDA authorised Afinitor on 30 March 2009
Marketing authorisations
FDA — authorised 29 August 2012
- Application: NDA203985
- Marketing authorisation holder: NOVARTIS PHARM
- Status: approved
FDA
- Status: approved
Afinitor 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 Afinitor approved in United States?
Yes. FDA authorised it on 30 March 2009; FDA authorised it on 29 August 2012; FDA has authorised it.
Who is the marketing authorisation holder for Afinitor in United States?
NOVARTIS holds the US marketing authorisation.