FDA — authorised 31 May 2005
- Application: BLA125117
- Marketing authorisation holder: BIOMARIN
- Local brand name: NAGLAZYME
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Naglazyme® in United States
FDA authorised Naglazyme® on 31 May 2005
Marketing authorisation
Naglazyme® in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare genetic disease / Lysosomal storage disorder approved in United States
Frequently asked questions
Is Naglazyme® approved in United States?
Yes. FDA authorised it on 31 May 2005.
Who is the marketing authorisation holder for Naglazyme® in United States?
BIOMARIN holds the US marketing authorisation.