FDA — authorised 1 June 2021
- Application: NDA211996
- Marketing authorisation holder: FOLDRX PHARMS
- Indication: Labeling
- Status: approved
🇺🇸 Vyndaqel in United States
FDA authorised Vyndaqel on 1 June 2021
Marketing authorisations
FDA — authorised 17 October 2023
- Application: NDA212161
- Marketing authorisation holder: FOLDRX PHARMS
- Indication: Labeling
- Status: approved
Vyndaqel 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 Vyndaqel approved in United States?
Yes. FDA authorised it on 1 June 2021; FDA authorised it on 17 October 2023.
Who is the marketing authorisation holder for Vyndaqel in United States?
FOLDRX PHARMS holds the US marketing authorisation.