December 9 , 2008
Our STN: BL 103921/5095
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 Tetanus and Diphtheria Toxoids Adsorbed, DECAVAC ® to revise the package insert to include editorial changes and updated data on spontaneously reported adverse events. Under this supplement, we have also approved a change in the nonproprietary name from Tetanus and Diphtheria Toxoids Adsorbed For Adult Use to Tetanus and Diphtheria Toxoids Adsorbed.
Under this approval, we acknowledge your written commitment of December 9, 2008, to submit a Supplement with a revised package insert incorporating additional safety and immunogencity data obtained from the DECAVAC ® group of study Td506, entitled “Safety and Immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (TdcP) Vaccine Compared to Tetanus and Diphtheria Toxoids Adsorbed (Td) in Adolescents and Adults 11 – 64 Years of Age". You have agreed to submit this Supplement by December 2009.
Please submit all final printed labeling and 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.
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