FDA — authorised 28 June 2024
- Application: ANDA218281
- Marketing authorisation holder: JIANGXI KVVIT PHARM
- Local brand name: ERIBULIN MESYLATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Eribulin-LF in United States
FDA authorised Eribulin-LF on 28 June 2024
Marketing authorisations
FDA — authorised 18 July 2024
- Application: ANDA214850
- Marketing authorisation holder: LONG GROVE PHARMS
- Local brand name: ERIBULIN MESYLATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 4 March 2025
- Application: ANDA218743
- Marketing authorisation holder: CHIA TAI TIANQING
- Local brand name: ERIBULIN MESYLATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 9 June 2025
- Application: ANDA214310
- Marketing authorisation holder: SANDOZ
- Local brand name: ERIBULIN MESYLATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 3 July 2025
- Application: ANDA217473
- Marketing authorisation holder: DR REDDYS
- Local brand name: ERIBULIN MESYLATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Frequently asked questions
Is Eribulin-LF approved in United States?
Yes. FDA authorised it on 28 June 2024; FDA authorised it on 18 July 2024; FDA authorised it on 4 March 2025.
Who is the marketing authorisation holder for Eribulin-LF in United States?
JIANGXI KVVIT PHARM holds the US marketing authorisation.