FDA — authorised 19 August 2014
- Marketing authorisation holder: GENZYME CORP
- Status: approved
🇺🇸 Cerdelga in United States
FDA authorised Cerdelga on 19 August 2014
Marketing authorisations
FDA — authorised 19 August 2014
- Application: NDA205494
- Marketing authorisation holder: GENZYME CORP
- Local brand name: CERDELGA
- Indication: CAPSULE — ORAL
- Status: approved
Cerdelga 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 Cerdelga approved in United States?
Yes. FDA authorised it on 19 August 2014; FDA authorised it on 19 August 2014.
Who is the marketing authorisation holder for Cerdelga in United States?
GENZYME CORP holds the US marketing authorisation.