FDA — authorised 17 January 2012
- Application: BLA125327
- Marketing authorisation holder: BTG INTERNATIONAL INC
- Local brand name: VORAXAZE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised Voraxaze on 17 January 2012
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 17 January 2012; FDA authorised it on 17 January 2012.
BTG INTERNATIONAL INC holds the US marketing authorisation.