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Vaccines, Blood & Biologics

December 9, 2008 Approval Letter - DECAVAC

December 9 , 2008

Our STN: BL 103921/5095

Sanofi Pasteur Inc.
Attention Gary K. Chikami, M.D.
Discovery Drive
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.

Sincerely yours,


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

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 02/23/2010
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