FDA — authorised 31 January 2002
- Marketing authorisation holder: AMGEN
- Status: approved
🇺🇸 Neulasta in United States
FDA authorised Neulasta on 31 January 2002
Marketing authorisations
FDA — authorised 21 March 2019
- Application: BLA761075
- Marketing authorisation holder: MYLAN GMBH
- Indication: Labeling
- Status: approved
FDA — authorised 16 April 2021
- Application: BLA761111
- Marketing authorisation holder: HOSPIRA INC
- Indication: Labeling
- Status: approved
FDA — authorised 26 May 2022
- Application: BLA761084
- Marketing authorisation holder: KASHIV BIOSCIENCES LLC
- Indication: Type 2 - New Active Ingredient
- Status: approved
FDA — authorised 18 August 2025
- Application: BLA125031
- Marketing authorisation holder: AMGEN
- Indication: Manufacturing (CMC)
- Status: approved
The FDA approved Neulasta, manufactured by AMGEN, for manufacturing (CMC) purposes on August 18, 2025. This approval was granted through a standard expedited pathway. The application number for this approval is BLA125031.
FDA — authorised 28 November 2025
- Application: BLA761212
- Marketing authorisation holder: LUPIN LTD
- Status: approved
Neulasta in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is Neulasta approved in United States?
Yes. FDA authorised it on 31 January 2002; FDA authorised it on 21 March 2019; FDA authorised it on 16 April 2021.
Who is the marketing authorisation holder for Neulasta in United States?
AMGEN holds the US marketing authorisation.