January 9, 2009 Approval Letter - Menomune-A/C/Y/W-135
Our STN: BL 103926/5099
Attn: Gary K. Chikami, M.D.
Sanofi Pasteur, Inc.
Swiftwater, PA 18370
Dear Dr. Chikami:
We have approved your request to supplement your biologics license application for Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined (Menomune®-A/C/Y/W-135) to revise the package insert to include additional safety and immunogenicity data from clinical trials and to update information on spontaneously reported adverse events.
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 as well as original paper copies (ten for circulars and five for other labels).
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
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research
Attachment: Approved Final Draft Labeling