FDA — authorised 8 November 2019
- Application: BLA761136
- Marketing authorisation holder: CELGENE CORP
- Local brand name: REBLOZYL
- Indication: POWDER — SUBCUTANEOUS
- Status: approved
🇺🇸 REBLOZYL in United States
FDA authorised REBLOZYL on 8 November 2019
Marketing authorisations
FDA
- Status: approved
REBLOZYL in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is REBLOZYL approved in United States?
Yes. FDA authorised it on 8 November 2019; FDA has authorised it.
Who is the marketing authorisation holder for REBLOZYL in United States?
CELGENE CORP holds the US marketing authorisation.