FDA — authorised 16 August 2021
- Application: ANDA213914
- Marketing authorisation holder: SUN PHARM
- Status: approved
🇺🇸 Sutent in United States
FDA authorised Sutent on 16 August 2021
Marketing authorisations
FDA — authorised 30 November 2021
- Application: ANDA213803
- Marketing authorisation holder: TEVA PHARMS USA
- Status: approved
FDA — authorised 6 December 2021
- Application: ANDA201275
- Marketing authorisation holder: MYLAN
- Indication: Not Applicable
- Status: approved
FDA — authorised 21 August 2023
- Application: ANDA218012
- Marketing authorisation holder: FOSUN WANBANG
- Status: approved
FDA — authorised 14 March 2024
- Application: ANDA218615
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
Sutent 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 Sutent approved in United States?
Yes. FDA authorised it on 16 August 2021; FDA authorised it on 30 November 2021; FDA authorised it on 6 December 2021.
Who is the marketing authorisation holder for Sutent in United States?
SUN PHARM holds the US marketing authorisation.