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U.S. Department of Health and Human Services

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December 16, 2010 Approval Letter - Menactra

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

December 16, 2010

Our STN: BL 125089-403

Sanofi Pasteur Inc.
Attention: Joseph H. Quinn
Discovery Drive, Swiftwater, PA 18370

Dear Mr. Quinn:

We have approved your request to supplement your biologics license application for Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diptheria Toxoid Conjugate Vaccine, Menactra®, to revise labeling to address latex information regarding the tip caps of the syringes. These labeling changes were made at CBER’s request since we have determined that information from the manufacturer of the tip caps is inadequate to support the claim that the tip caps do not contain latex.

Please submit all final printed labeling at the time of use and include implementation information on Form FDA 356h. Please provide content of labeling in Structured Product Labeling format. Please provide carton and container labeling in Structured Product Labeling format, as well as three original paper copies.

We will include the information contained in the above referenced 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 Final Draft Labeling Labeling