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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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April 27, 2005 Approval Letter

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

April 27, 2005

Submission Tracking Numbers (STN): BL 103821/5070

David H. Willis, Ph.D.
BioPort Corporation
3500 N. Martin Luther King, Jr. Blvd.
Lansing, MI 48906

Dear Dr. Willis:

The Supplement to your Biologics License Application for Anthrax Vaccine Adsorbed (BioThrax) to include an extension of dating to 36 months has been approved. Under this approval, the dating period for final container product will be 36 months when the product is stored at 2-8 °C.

This information will be included in your License Application file.

Sincerely yours,

--- signature ---

Richard I. Walker, Ph.D.
Division of Bacterial, Parasitic and Allergenic Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research