Our STN: STN 103921/5143
Sanofi Pasteur Inc.
Attention: Joseph Quinn
Swiftwater, PA 18370
Dear Mr. Quinn:
We have approved your request to supplement your biologics license application (BLA) for Tetanus and Diphtheria Toxoids Adsorbed (DECAVAC®), to revise the package insert to include additional safety and immunogenicity data obtained from the DECAVAC group of study Td506.
Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels. In addition, please submit three original paper copies for carton and container final printed labeling. All final labeling should be submitted as Product Correspondence to this BLA at the time of use (prior to marketing) and include implementation information on FDA Form 356h.
In addition, please submit the final content of labeling (21 CFR 601.14) in SPL format via the FDA automated drug registration and listing system, eLIST, as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling
/default.htm. Information on submitting SPL files using eLIST may be found in the guidance for industry titled, “SPL Standard for Content of Labeling Technical Qs and As” at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
You may submit two 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, Rockville, MD 20852-1448. You must submit copies of your final advertisement and promotional labeling at the time of initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR 601.12(f)(4)).
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence or substantial clinical experience to support such claims (21 CFR 202.1(e)(6)).
Please submit an amendment to all pending supplemental applications for this BLA that include revised labeling incorporating a revised content of labeling that includes these changes.
This fulfills your commitment to submit a Supplement with a revised package insert incorporating additional safety and immunogenicity 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," as stated in your commitment in the December 9, 2008, approval letter for STN 103921/5095.
AGREED UPON POSTMARKETING COMMITMENTS
Postmarketing Studies subject to reporting requirements of 21 CFR 601.70.
We acknowledge your written commitment as described in your amendment of March 4, 2011, as outlined below:
1. To submit a supplement to the biologics license application for Tetanus and Diphtheria Toxoids Adsorbed, DECAVAC, to revise the package insert to include safety and immunogenicity data on use of DECAVAC in persons 65 years of age and older from completed Study Td515 "Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®) in Persons >65 Years of Age".
- The final study report and supplement will be submitted by February 2012.
Please submit clinical protocols to your IND, with a cross-reference letter to this supplement to your BLA, STN BL 103921. Submit nonclinical and chemistry, manufacturing, and controls protocols and all study final reports to your BLA, STN BL 103921. If the information in the final study report supports a change in the labeling, the final study report should be submitted as a supplement. We may also request a supplement if we think labeling changes are needed. Please use the following designators to label prominently all submissions, including supplements, relating to these postmarketing study commitments as appropriate:
- Postmarketing Study Commitment Protocol
- Postmarketing Study Correspondence
- Postmarketing Study Commitment – Final Study Report
- Supplement Contains Postmarketing Study Commitments – Final Study Report
For each postmarketing study subject to the reporting requirements of 21 CFR 601.70, you must describe the status in an annual report on postmarketing studies for this product. Label your annual report an “Annual Status Report of Postmarketing Study Commitments.” The status report for each study should include:
- information to identify and describe the postmarketing commitment,
- the original schedule for the commitment,
- the status of the commitment (i.e., pending, ongoing, delayed, terminated, or submitted), and
- an explanation of the status including, for clinical studies, the patient accrual rate (i.e., number enrolled to date and the total planned enrollment).
As described in 21 CFR 601.70(e), we may publicly disclose information regarding these postmarketing studies on our Web site (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm). Please refer to the February 2006 Guidance for Industry: Reports on the Status of Postmarketing Studies – Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (see http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/Guidances/UCM080569.pdf) for further information.
We will include information contained in the above-referenced supplement in your BLA file.
Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccine
Research and Review
Center for Biologics
Evaluation and Research