October 7, 2008
Our STN: BL 125089/ 223
Sanofi Pasteur Inc.
Attention: Gary K. Chikami, M.D.
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.
--- signature ---
Wellington Sun, M.D.
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Draft Labeling