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 Product Approval Information - Licensing Action

Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

April 2, 1998

Our Reference No.: 96-l136

N. Kirby Alton, Ph.D.
Amgen, Inc.
1840 DeHavilland Drive
Thousand Oaks, CA 91320-1789

Dear Dr. Alton: Your request to supplement your biologics license application for Filgrastim to include a new indication for the use of Filgrastim in patients with Acute Myeloid Leukemia has been approved.

Please submit three copies of final printed labeling at the time of use and include part II of the label transmittal form with completed implementation information.

This information will be included in your biologics license application file.

Sincerely yours,

 --- signature ---

Karen D. Weiss, M.D.
Division of Clinical Trial Design and Analysis
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research

Last Updated: 1/23/2001

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Date created: September 25, 2003

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