FDA — authorised 31 May 2005
- Application: BLA125117
- Marketing authorisation holder: BIOMARIN
- Indication: Type 1 - New Molecular Entity
- Status: approved
FDA authorised Aryplase on 31 May 2005
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 31 May 2005.
BIOMARIN holds the US marketing authorisation.