FDA — authorised 7 March 2008
- Marketing authorisation holder: SPECTRUM PHARMS
- Status: approved
🇺🇸 Fusilev in United States
FDA authorised Fusilev on 7 March 2008
Marketing authorisations
FDA — authorised 7 March 2008
- Application: NDA020140
- Marketing authorisation holder: ACROTECH BIOPHARMA
- Local brand name: FUSILEV
- Indication: SOLUTION — INTRAVENOUS
- 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 7 March 2008; FDA authorised it on 7 March 2008.
Who is the marketing authorisation holder for Fusilev in United States?
SPECTRUM PHARMS holds the US marketing authorisation.