FDA — authorised 8 February 2023
- Application: ANDA211846
- Marketing authorisation holder: SUN PHARM
- Status: approved
🇺🇸 Revlimid in United States
FDA authorised Revlimid on 8 February 2023
Marketing authorisations
FDA — authorised 6 March 2023
- Application: ANDA210480
- Marketing authorisation holder: ALVOGEN
- Status: approved
FDA — authorised 5 October 2023
- Application: ANDA210154
- Marketing authorisation holder: ZYDUS PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 31 January 2025
- Application: ANDA216213
- Marketing authorisation holder: AMNEAL
- Status: approved
FDA — authorised 22 May 2025
- Application: ANDA217554
- Marketing authorisation holder: DEVA HOLDING AS
- Status: approved
Revlimid 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 Revlimid approved in United States?
Yes. FDA authorised it on 8 February 2023; FDA authorised it on 6 March 2023; FDA authorised it on 5 October 2023.
Who is the marketing authorisation holder for Revlimid in United States?
SUN PHARM holds the US marketing authorisation.