Product Approval Information - Licensing Action
March 30, 2007
Our STN: BL 125089/3
Sanofi Pasteur Inc.
Attention: Gary Chikami, M.D.
Discovery Drive
Swiftwater, PA 18370
Dear Dr. Chikami:
We have approved your request to supplement your biologics license application for Meningococcal Groups (A, C, Y and W135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®), to include a single dose syringe presentation.
Under this approval, lots of Menactra® in a single dose syringe presentation will have an expiration dating period of 18 months when stored at 2-8° C. Any requests to extend the dating period beyond 18 months will require the submission of supporting data as a Prior Approval Supplement to your license application for review and approval.
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.
We will include information contained in the above-referenced supplement in your biologics license application file.
Sincerely yours,
--- signature ---
Richard I. Walker, Ph.D.
Director
Division of Bacterial, Parasitic and Allergenic Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeling