FDA — authorised 13 December 2007
- Application: NDA022181
- Marketing authorisation holder: BIOMARIN PHARM
- Local brand name: KUVAN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Tetrahydrobiopterin in United States
FDA authorised Tetrahydrobiopterin on 13 December 2007
Marketing authorisations
FDA — authorised 19 December 2013
- Application: NDA205065
- Marketing authorisation holder: BIOMARIN PHARM
- Local brand name: KUVAN
- Indication: POWDER — ORAL
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Tetrahydrobiopterin approved in United States?
Yes. FDA authorised it on 13 December 2007; FDA authorised it on 19 December 2013.
Who is the marketing authorisation holder for Tetrahydrobiopterin in United States?
BIOMARIN PHARM holds the US marketing authorisation.