FDA — authorised 2 June 2014
- Application: NDA202714
- Marketing authorisation holder: ONYX PHARMS AMGEN
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Kyprolis in United States
FDA authorised Kyprolis on 2 June 2014
Marketing authorisations
FDA — authorised 9 September 2019
- Application: ANDA209422
- Marketing authorisation holder: DR REDDYS
- Local brand name: CARFILZOMIB
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 16 March 2020
- Application: ANDA209425
- Marketing authorisation holder: APOTEX
- Local brand name: CARFILZOMIB
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 11 June 2021
- Application: ANDA209330
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: CARFILZOMIB
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA
- Application: ANDA219276
- Marketing authorisation holder: HAINAN POLY PHARM. CO., LTD.
- Local brand name: CARFILZOMIB
- Indication: POWDER
- Status: approved
Kyprolis 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 Kyprolis approved in United States?
Yes. FDA authorised it on 2 June 2014; FDA authorised it on 9 September 2019; FDA authorised it on 16 March 2020.
Who is the marketing authorisation holder for Kyprolis in United States?
ONYX PHARMS AMGEN holds the US marketing authorisation.