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 Product Approval Information - Licensing Action

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

June 5, 2003

Our STN: BL 103795 / 5109

Douglas Hunt
Immunex Corporation
One Amgen Center Drive
Mailstop 24-2-C
Thousand Oaks , CA 91320

Dear Mr. Hunt:

Your request to supplement your biologics license application for Etanercept to revise the package insert to include information regarding concurrent Etanercept and Anakinra therapy has been approved.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels).

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

Sincerely yours,

--- signature ---

Patricia Keegan, M.D.
Acting Director
Division of Clinical Trials Design
    and Analysis
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research

Last Updated: 6/17/2003


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Date created: September 25, 2003

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