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U.S. Department of Health and Human Services


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Pegfilgrastim Product Approval Information - Licensing Action

Proper name: Pegfilgrastim
Tradename: Neulasta
Manufacturer: Amgen, Inc, Thousand Oaks, CA, License #1080
Indication for Use: To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia
Approval Date: 1/31/2002
Type of submission: Biologics license application


Label (PDF)

Patient Label (PDF)