FDA — authorised 29 September 2022
- Marketing authorisation holder: AMYLYX
- Status: approved
FDA authorised Relyvrio on 29 September 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 29 September 2022.
AMYLYX holds the US marketing authorisation.