FDA — authorised 28 December 2004
- Marketing authorisation holder: GENZYME
- Status: approved
🇺🇸 Clolar in United States
FDA authorised Clolar on 28 December 2004
Marketing authorisations
FDA — authorised 9 May 2017
- Application: ANDA204029
- Marketing authorisation holder: ABON PHARMS LLC
- Local brand name: CLOFARABINE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 6 November 2017
- Application: ANDA205375
- Marketing authorisation holder: DR REDDYS
- Local brand name: CLOFARABINE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 6 December 2017
- Application: ANDA209775
- Marketing authorisation holder: MSN
- Local brand name: CLOFARABINE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 31 October 2018
- Application: ANDA207831
- Marketing authorisation holder: GLAND
- Local brand name: CLOFARABINE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 27 December 2018
- Application: ANDA210283
- Marketing authorisation holder: HOSPIRA
- Local brand name: CLOFARABINE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 22 February 2019
- Application: ANDA212034
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: CLOFARABINE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 3 October 2022
- Application: ANDA212457
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: CLOFARABINE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 3 January 2025
- Application: ANDA216233
- Marketing authorisation holder: SCINOPHARM TAIWAN
- Local brand name: CLOFARABINE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Clolar 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 Clolar approved in United States?
Yes. FDA authorised it on 28 December 2004; FDA authorised it on 9 May 2017; FDA authorised it on 6 November 2017.
Who is the marketing authorisation holder for Clolar in United States?
GENZYME holds the US marketing authorisation.