Product Approval Information

March 12, 2008

Our STN: BL 103666/5158

Sanofi Pasteur Limited
Attn: Gary Chikami, M.D.
1755 Steeles Avenue West
Toronto, ON Canada M2R 3T4

Dear Dr. Chikami:

We have approved your request to supplement your biologics license application for Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DAPTACEL®) to include a fifth dose booster immunization at 4 to 6 years of age following four previous doses of DAPTACEL.

This fulfills your commitment to assess the use of DAPTACEL as a fifth dose at 4-6 years of age following four previous doses of DAPTACEL as stated in commitment #1 of the May 14, 2002, approval letter.

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 are waiving the pediatric study requirement for ages birth to 6 weeks for the following reasons:

  1. Necessary studies are impossible or highly impracticable because of the lack of apparent benefit of vaccination against diphtheria and tetanus in this age group over vaccination beginning at 6 weeks of age.

  2. DAPTACEL does not represent a meaningful therapeutic benefit over existing therapies and is not likely to be used by a substantial number of infants from birth to 6 weeks of age.

We are waiving the pediatric study requirement for ages 7 to 16 years of age for the following reasons:

  1. Necessary studies are impossible or highly impracticable because a fifth dose of DTaP, routinely administered at age 4-6 years, completes the recommended series for this vaccine; and a single dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) is recommended at 11-12 years of age. With regard to the age group 7-9 years, for which there are no licensed pertussis vaccines in the U.S., a very small number of children, geographically dispersed, would be expected to need vaccination against diphtheria, tetanus, and pertussis.

  2. DAPTACEL does not represent a meaningful therapeutic benefit over existing therapies and is not likely to be used by a substantial number of children and adolescents 7-16 years of age.

We note that you have fulfilled the pediatric study requirement for ages 6 weeks to 6 years for this application.

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). In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, MD 20852-1448. Please submit your final printed advertising and promotional labeling at the time of initial dissemination, accompanied by an FDA Form 2253.

We will include information contained in the above-referenced supplement in your biologics license applications file.

Sincerely yours,

/Loris D. McVittie, Ph.D./ Loris D. McVittie, Ph.D.
Acting Director
Division of Vaccines and Related Product Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Attachment: Approved Package Insert Labeling

 
Updated: March 13, 2008