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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

October 7, 2008 Approval Letter-Menactra

October 7, 2008

Our STN: BL 125089/ 223

Sanofi Pasteur Inc.
Attention: Gary K. Chikami, M.D.
Discovery Drive
Swiftwater, PA 18370-0187

Dear Dr. Chikami:

We have approved your request to supplement your biologics license application for Meningococcal Groups (A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, to include changes to the package insert. This is for a change in the package insert to incorporate post-marketing safety information regarding anaphylaxis.

Please submit all final printed labeling at the time of use and include implementation information on Form FDA 356h. Please provide this labeling as a PDF-format electronic copy.

We will include the information contained in the above-reference supplement in your biologics license application file.

Sincerely yours,

--- signature ---

Wellington Sun, M.D.
Director
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Attachment: Approved Draft Labeling


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