FDA — authorised 29 September 2022
- Application: NDA216660
- Marketing authorisation holder: AMYLYX
- Local brand name: RELYVRIO
- Indication: FOR SUSPENSION — ORAL
- Status: approved
🇺🇸 AMX0035 in United States
FDA authorised AMX0035 on 29 September 2022
Marketing authorisation
Other Neurology approved in United States
Frequently asked questions
Is AMX0035 approved in United States?
Yes. FDA authorised it on 29 September 2022.
Who is the marketing authorisation holder for AMX0035 in United States?
AMYLYX holds the US marketing authorisation.