🇺🇸 pegfiligrastim in United States

FDA authorised pegfiligrastim on 31 January 2002

Marketing authorisation

FDA — authorised 31 January 2002

  • Application: BLA125031
  • Marketing authorisation holder: AMGEN
  • Local brand name: NEULASTA
  • Indication: SYRINGE
  • Status: approved

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Other Other approved in United States

Frequently asked questions

Is pegfiligrastim approved in United States?

Yes. FDA authorised it on 31 January 2002.

Who is the marketing authorisation holder for pegfiligrastim in United States?

AMGEN holds the US marketing authorisation.