August 3, 2009
Our STN: 125089/324
Sanofi Pasteur Inc.
Attention: Gary Chikami, M.D.
Swiftwater, PA 18370
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 revise the labeling to include changes to the package insert regarding formaldehyde levels.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy.
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.
We will include information contained in the above-referenced supplement in your biologics license application file.
Wellington Sun, MD
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research