FDA — authorised 30 June 2016
- Application: NDA204026
- Marketing authorisation holder: BRISTOL
- Indication: Labeling
- Status: approved
🇺🇸 Pomalyst in United States
FDA authorised Pomalyst on 30 June 2016
Marketing authorisations
FDA — authorised 28 May 2021
- Application: ANDA210249
- Marketing authorisation holder: EUGIA PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 26 September 2024
- Application: ANDA210236
- Marketing authorisation holder: HETERO LABS LTD V
- Status: approved
FDA — authorised 26 February 2025
- Application: ANDA210164
- Marketing authorisation holder: APOTEX
- Indication: REMS
- Status: approved
The FDA approved Pomalyst for marketing in the United States on 26 February 2025. The approval was granted to APOTEX under standard expedited pathway, with application number ANDA210164. The approved indication for Pomalyst is under a Risk Evaluation and Mitigation Strategy (REMS).
FDA — authorised 5 August 2025
- Application: ANDA209956
- Marketing authorisation holder: TEVA PHARMS USA
- Indication: REMS
- Status: approved
Teva Pharms USA received marketing authorisation from the FDA for Pomalyst on 05 August 2025. The approved indication is for a Risk Evaluation and Mitigation Strategy (REMS) programme. The application number for this approval is ANDA209956.
Pomalyst 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 Pomalyst approved in United States?
Yes. FDA authorised it on 30 June 2016; FDA authorised it on 28 May 2021; FDA authorised it on 26 September 2024.
Who is the marketing authorisation holder for Pomalyst in United States?
BRISTOL holds the US marketing authorisation.