FDA — authorised 1 August 2017
- Marketing authorisation holder: CELGENE CORP
- Status: approved
🇺🇸 Idhifa in United States
FDA authorised Idhifa on 1 August 2017
Marketing authorisations
FDA — authorised 26 July 2021
- Application: NDA209606
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Indication: Manufacturing (CMC)
- Status: approved
Idhifa 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 Idhifa approved in United States?
Yes. FDA authorised it on 1 August 2017; FDA authorised it on 26 July 2021.
Who is the marketing authorisation holder for Idhifa in United States?
CELGENE CORP holds the US marketing authorisation.