FDA — authorised 20 July 2023
- Marketing authorisation holder: DAIICHI SANKYO INC
- Status: approved
🇺🇸 Vanflyta in United States
FDA authorised Vanflyta on 20 July 2023
Marketing authorisations
FDA — authorised 20 July 2023
- Application: NDA216993
- Marketing authorisation holder: DAIICHI SANKYO INC
- Local brand name: VANFLYTA
- Indication: TABLET — ORAL
- Status: approved
Vanflyta 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 Vanflyta approved in United States?
Yes. FDA authorised it on 20 July 2023; FDA authorised it on 20 July 2023.
Who is the marketing authorisation holder for Vanflyta in United States?
DAIICHI SANKYO INC holds the US marketing authorisation.