FDA — authorised 19 August 2014
- Application: NDA205494
- Marketing authorisation holder: GENZYME CORP
- Local brand name: CERDELGA
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Eliglustat GZ385660 in United States
FDA authorised Eliglustat GZ385660 on 19 August 2014
Marketing authorisation
Eliglustat GZ385660 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Eliglustat GZ385660 approved in United States?
Yes. FDA authorised it on 19 August 2014.
Who is the marketing authorisation holder for Eliglustat GZ385660 in United States?
GENZYME CORP holds the US marketing authorisation.