FDA — authorised 14 September 2018
- Application: ANDA210892
- Marketing authorisation holder: GLAND
- Status: approved
🇺🇸 Fusilev in United States
FDA authorised Fusilev on 14 September 2018
Marketing authorisations
FDA — authorised 19 October 2018
- Application: NDA211226
- Marketing authorisation holder: ACROTECH BIOPHARMA
- Local brand name: KHAPZORY
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 22 August 2019
- Application: ANDA211003
- Marketing authorisation holder: MEITHEAL
- Status: approved
FDA — authorised 22 May 2023
- Application: ANDA217314
- Marketing authorisation holder: HAINAN POLY PHARM
- Status: approved
FDA — authorised 22 September 2023
- Application: ANDA211002
- Marketing authorisation holder: MEITHEAL
- Indication: Labeling
- Status: approved
Fusilev 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 Fusilev approved in United States?
Yes. FDA authorised it on 14 September 2018; FDA authorised it on 19 October 2018; FDA authorised it on 22 August 2019.
Who is the marketing authorisation holder for Fusilev in United States?
GLAND holds the US marketing authorisation.