FDA — authorised 8 July 2022
- Marketing authorisation holder: PROVEPHARM SAS
- Status: approved
FDA authorised Bludigo on 8 July 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 8 July 2022.
PROVEPHARM SAS holds the US marketing authorisation.