FDA — authorised 24 May 2018
- Application: BLA761079
- Marketing authorisation holder: BIOMARIN PHARM
- Status: supplemented
🇺🇸 Palynziq in United States
FDA authorised Palynziq on 24 May 2018
Marketing authorisations
FDA
- Status: approved
Palynziq in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Palynziq approved in United States?
Yes. FDA authorised it on 24 May 2018; FDA has authorised it.
Who is the marketing authorisation holder for Palynziq in United States?
BIOMARIN PHARM holds the US marketing authorisation.