FDA — authorised 29 December 2021
- Application: NDA207949
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: CABAZITAXEL
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Jevtana in United States
FDA authorised Jevtana on 29 December 2021
Marketing authorisations
FDA — authorised 14 March 2024
- Application: NDA207970
- Marketing authorisation holder: ACTAVIS
- Local brand name: CABAZITAXEL
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA
- Application: NDA207937
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CABAZITAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA208715
- Marketing authorisation holder: SANDOZ
- Local brand name: CABAZITAXEL
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Other Oncology approved in United States
Frequently asked questions
Is Jevtana approved in United States?
Yes. FDA authorised it on 29 December 2021; FDA authorised it on 14 March 2024; FDA has authorised it.
Who is the marketing authorisation holder for Jevtana in United States?
ACCORD HLTHCARE holds the US marketing authorisation.