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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

September 23, 2005 Approval Letter - Tetanus Toxoid Adsorbed

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

September 23, 2005

Our STN: BL 103913/5047

Attn: Luc Kuykens, M.D., D.T.M., M.P.H.

Aventis Pasteur Inc.

Discovery Drive

Swiftwater, PA 18370

Dear Dr. Kuykens

We have approved your request to supplement your biologics license application for Tetanus Toxoid Adsorbed, to include the addition of a single dose vial formulation that is preservative free.

Under this approval, the expiration date for the preservative-free single dose vial formulation of Tetanus Toxoid Adsorbed will be 24 months when stored at 2-8o C. Any requests to extend the dating period beyond 24 months will require the submission of a supplement to your biologics license application with supporting data.

All applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens are required to contain an assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is waived or deferred. We have reviewed your submission and agree that a partial waiver of your pediatric studies is justified because Tetanus Toxoid Adsorbed (Preservative-free) vaccine does not represent a meaningful therapeutic benefit over existing vaccines for pediatric patients less than seven years of age and it is not likely to be used by a substantial number of pediatric patients in that age group.

We acknowledge your written commitments as described in your original submission of February 28, 2005, as outlined below:

 

  1. To add the next two manufactured lots of Tetanus Toxoid Adsorbed (Preservative-free) to your stability testing program and to submit to CBER the stability data from all 3 lots as they become available.

In addition, we acknowledge your written commitments as described in your letter of September 15, 2005, as outlined below:

 

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Please submit all final printed labeling and implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as one original paper 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: Final Draft Labeling