FDA — authorised 8 December 2015
- Marketing authorisation holder: Baxalta US Inc.
- Status: approved
FDA authorised Vonvendi on 8 December 2015
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 8 December 2015.
Baxalta US Inc. holds the US marketing authorisation.