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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
Approval Letter
(Text)
Label
(PDF)
Patient Label
(PDF)
Last Updated: 2/1/2002
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Updated: September 25, 2003 |
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