FDA — authorised 13 December 2007
- Marketing authorisation holder: BIOMARIN PHARM
- Status: approved
🇺🇸 Kuvan in United States
FDA authorised Kuvan on 13 December 2007
Marketing authorisations
FDA — authorised 26 May 2022
- Application: ANDA207685
- Marketing authorisation holder: DR REDDYS
- Indication: Labeling
- Status: approved
FDA — authorised 18 August 2022
- Application: ANDA215420
- Marketing authorisation holder: ANNORA PHARMA
- Status: approved
FDA — authorised 15 March 2024
- Application: ANDA209452
- Marketing authorisation holder: DR REDDYS
- Indication: Labeling
- Status: approved
The FDA approved Kuvan for labeling indication. This approval was granted to DR REDDYS on 2024-03-15. The application number for this approval is ANDA209452.
FDA — authorised 15 March 2024
- Application: ANDA215798
- Marketing authorisation holder: DR REDDYS
- Indication: Labeling
- Status: approved
The FDA approved Kuvan, manufactured by DR REDDYS, on 2024-03-15. This approval was granted under the standard expedited pathway. The approved indication for Kuvan is listed in the labeling, but the specific indication and local brand name are not reported.
FDA — authorised 9 June 2025
- Application: ANDA216797
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
Kuvan in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Kuvan approved in United States?
Yes. FDA authorised it on 13 December 2007; FDA authorised it on 26 May 2022; FDA authorised it on 18 August 2022.
Who is the marketing authorisation holder for Kuvan in United States?
BIOMARIN PHARM holds the US marketing authorisation.