FDA — authorised 16 August 2021
- Application: ANDA213914
- Marketing authorisation holder: SUN PHARM
- Local brand name: SUNITINIB MALATE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Sutent in United States
FDA authorised Sutent on 16 August 2021
Marketing authorisations
FDA — authorised 14 February 2025
- Application: ANDA214824
- Marketing authorisation holder: MSN
- Local brand name: SUNITINIB MALATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- 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 14 February 2025; FDA has authorised it.
Who is the marketing authorisation holder for Sutent in United States?
SUN PHARM holds the US marketing authorisation.