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U.S. Department of Health and Human Services

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Filgrastim Approval Information - Licensing Action

Proper name: Filgrastim
Tradename: Neupogen
Manufacturer: Amgen, Inc, Thousand Oaks, CA, License #1080
Indication for Use: New indication for use in patients with acute myeloid leukemia
Approval Date: 4/2/98
Type of submission: Biologics license application supplement

 


Approval Letter (PDF)

Label (PDF)

Reviews - (PDF)
      Biostatistical (7 pages)
      Clinical (20 pages)