FDA — authorised 30 March 2012
- Application: NDA022334
- Marketing authorisation holder: NOVARTIS
- Indication: Labeling
- Status: approved
🇺🇸 Afinitor in United States
FDA authorised Afinitor on 30 March 2012
Marketing authorisations
FDA — authorised 29 August 2012
- Application: NDA203985
- Marketing authorisation holder: NOVARTIS PHARM
- Local brand name: AFINITOR DISPERZ
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 19 April 2019
- Application: ANDA210130
- Marketing authorisation holder: MYLAN
- Local brand name: EVEROLIMUS
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 9 December 2019
- Application: ANDA210050
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: EVEROLIMUS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 December 2019
- Application: ANDA207934
- Marketing authorisation holder: PH HEALTH
- Local brand name: EVEROLIMUS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 June 2020
- Application: ANDA207486
- Marketing authorisation holder: HIKMA
- Local brand name: EVEROLIMUS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2021
- Application: ANDA214182
- Marketing authorisation holder: BIOCON PHARMA
- Status: approved
FDA — authorised 18 October 2021
- Application: ANDA205775
- Marketing authorisation holder: PH HEALTH
- Status: approved
FDA — authorised 30 April 2024
- Application: ANDA206133
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
The FDA approved Afinitor for labeling indications on April 30, 2024. The marketing authorization holder is HIKMA. The application number for this approval is ANDA206133. Afinitor was approved under the standard expedited pathway.
FDA — authorised 4 October 2024
- Application: ANDA214138
- Marketing authorisation holder: ALKEM LABS LTD
- Indication: Labeling
- Status: approved
The FDA approved Afinitor for its approved indication on 4 October 2024. The marketing authorisation was granted to Alkem Labs Ltd. The application number for this approval is ANDA214138. The approval was granted through the standard expedited pathway.
FDA — authorised 10 January 2025
- Application: ANDA218863
- Marketing authorisation holder: AMNEAL
- Local brand name: EVEROLIMUS
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 9 April 2025
- Application: ANDA216140
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: EVEROLIMUS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 October 2025
- Application: ANDA219955
- Marketing authorisation holder: NOVUGEN
- Local brand name: EVEROLIMUS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 2026
- Application: ANDA219533
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: EVEROLIMUS
- Indication: TABLET — ORAL
- 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 2012; FDA authorised it on 29 August 2012; FDA authorised it on 19 April 2019.
Who is the marketing authorisation holder for Afinitor in United States?
NOVARTIS holds the US marketing authorisation.