FDA — authorised 8 August 2018
- Marketing authorisation holder: AMICUS THERAPS US
- Status: approved
🇺🇸 Galafold in United States
FDA authorised Galafold on 8 August 2018
Marketing authorisations
FDA — authorised 10 August 2018
- Application: NDA208623
- Marketing authorisation holder: AMICUS THERAP US
- Local brand name: GALAFOLD
- Indication: CAPSULE — ORAL
- Status: approved
Galafold in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Galafold approved in United States?
Yes. FDA authorised it on 8 August 2018; FDA authorised it on 10 August 2018.
Who is the marketing authorisation holder for Galafold in United States?
AMICUS THERAPS US holds the US marketing authorisation.