DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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.
--- 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