FDA — authorised 8 November 2019
- Marketing authorisation holder: CELGENE CORP
- Status: approved
🇺🇸 Reblozyl in United States
FDA authorised Reblozyl on 8 November 2019
Marketing authorisations
FDA — authorised 16 May 2024
- Application: BLA761136
- Marketing authorisation holder: CELGENE CORP
- Indication: Labeling
- Status: approved
The FDA approved Reblozyl, a product of Celgene Corp, for its approved indication on 16 May 2024. The application number for this approval is BLA761136. Reblozyl was approved through the standard expedited pathway.
Reblozyl in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is Reblozyl approved in United States?
Yes. FDA authorised it on 8 November 2019; FDA authorised it on 16 May 2024.
Who is the marketing authorisation holder for Reblozyl in United States?
CELGENE CORP holds the US marketing authorisation.