FDA — authorised 31 August 2022
- Application: BLA761261
- Marketing authorisation holder: GENZYME CORP
- Local brand name: XENPOZYME
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised XENPOZYME on 31 August 2022
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 31 August 2022.
GENZYME CORP holds the US marketing authorisation.