FDA — authorised 6 August 2021
- Application: BLA761194
- Marketing authorisation holder: GENZYME CORP
- Local brand name: NEXVIAZYME
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised NEXVIAZYME on 6 August 2021
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 6 August 2021.
GENZYME CORP holds the US marketing authorisation.