FDA — authorised 30 April 2003
- Marketing authorisation holder: BIOMARIN
- Status: approved
🇺🇸 Aldurazyme in United States
FDA authorised Aldurazyme on 30 April 2003
Marketing authorisations
FDA — authorised 20 May 2009
- Application: BLA125058
- Marketing authorisation holder: BIOMARIN
- Indication: Efficacy
- Status: approved
Aldurazyme 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 Aldurazyme approved in United States?
Yes. FDA authorised it on 30 April 2003; FDA authorised it on 20 May 2009.
Who is the marketing authorisation holder for Aldurazyme in United States?
BIOMARIN holds the US marketing authorisation.