FDA — authorised 1 September 2020
- Application: NDA209510
- Marketing authorisation holder: ACACIA
- Indication: Manufacturing (CMC)
- Status: approved
FDA authorised Barhemsys on 1 September 2020
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 1 September 2020.
ACACIA holds the US marketing authorisation.