FDA — authorised 7 August 2020
- Application: NDA213535
- Marketing authorisation holder: GENENTECH INC
- Local brand name: EVRYSDI
- Indication: FOR SOLUTION — ORAL
- Status: approved
🇺🇸 Evrysdi in United States
FDA authorised Evrysdi on 7 August 2020
Marketing authorisations
FDA — authorised 11 February 2025
- Application: NDA219285
- Marketing authorisation holder: GENENTECH INC
- Local brand name: EVRYSDI
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Evrysdi in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Evrysdi approved in United States?
Yes. FDA authorised it on 7 August 2020; FDA authorised it on 11 February 2025; FDA has authorised it.
Who is the marketing authorisation holder for Evrysdi in United States?
GENENTECH INC holds the US marketing authorisation.