FDA — authorised 5 March 1991
- Marketing authorisation holder: BERLEX LABS
- Status: approved
🇺🇸 Leukine in United States
FDA authorised Leukine on 5 March 1991
Marketing authorisations
FDA — authorised 4 November 2008
- Application: BLA103362
- Marketing authorisation holder: BERLEX LABS
- Indication: Labeling
- Status: approved
Leukine 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 Leukine approved in United States?
Yes. FDA authorised it on 5 March 1991; FDA authorised it on 4 November 2008.
Who is the marketing authorisation holder for Leukine in United States?
BERLEX LABS holds the US marketing authorisation.