FDA — authorised 23 June 2017
- Application: NDA208383
- Marketing authorisation holder: PORTOLA PHARMS INC
- Local brand name: BEVYXXA
- Indication: CAPSULE — ORAL
- Status: approved
FDA authorised Bevyxxa on 23 June 2017
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 23 June 2017; FDA has authorised it.
PORTOLA PHARMS INC holds the US marketing authorisation.