FDA — authorised 29 December 2021
- Application: NDA207949
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: CABAZITAXEL
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 CABAZITAXEL in United States
FDA authorised CABAZITAXEL on 29 December 2021
Marketing authorisations
FDA — authorised 23 June 2022
- Application: ANDA207619
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: CABAZITAXEL
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 26 October 2022
- Application: ANDA207693
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: CABAZITAXEL
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 10 February 2023
- Application: ANDA207718
- Marketing authorisation holder: DR REDDYS
- Local brand name: CABAZITAXEL
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 14 March 2024
- Application: NDA207970
- Marketing authorisation holder: ACTAVIS
- Local brand name: CABAZITAXEL
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA
- Application: ANDA207735
- Marketing authorisation holder: BPI LABS LLC
- Local brand name: CABAZITAXEL
- Indication: UNKNOWN — UNKNOWN
- Status: approved
FDA
- Application: NDA207937
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CABAZITAXEL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
FDA
- Application: NDA208715
- Marketing authorisation holder: SANDOZ
- Local brand name: CABAZITAXEL
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
CABAZITAXEL in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is CABAZITAXEL approved in United States?
Yes. FDA authorised it on 29 December 2021; FDA authorised it on 23 June 2022; FDA authorised it on 26 October 2022.
Who is the marketing authorisation holder for CABAZITAXEL in United States?
ACCORD HLTHCARE holds the US marketing authorisation.