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May 3, 2005 Approval Letter - Boostrix

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

May 3, 2005

Our STN: BL 125106/0

GLAXOSMITHKLINE BIOLOGICALS
Attention: Ms. Donna Boyce
Director, CMC, Pediatric Vaccines
U.S. Regulatory Affairs
2301 Renaissance Boulevard
Building 510,
P.O. Box 61540
King of Prussia, PA 19406-2772

Dear Ms. Boyce:

We have approved your Biologics License Application (BLA) for Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed effective this date. You are hereby authorized to introduce or deliver for introduction into interstate commerce, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed under your existing Department of Health and Human Services U.S. License No. 1617. Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed is indicated for booster immunization against tetanus, diphtheria and pertussis as a single dose in adolescents 10-18 years of age.

Under this authorization, you are approved to manufacture Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed at GlaxoSmithKline Biologicals in Rixensart, Belgium. The final formulation is performed by GlaxoSmithKline Biologicals SA in Rixensart, Belgium. Product will be filled by GlaxoSmithKline Biologicals SA in Rixensart, or Wavre, Belgium. Labeling and packaging will be performed by GlaxoSmithKline Biologicals SA at the latter facility. You may label your product with the proprietary name Boostrix and you will market Boostrix in 0.5mL single dose vials and single dose syringes.

The dating period for Boostrix vaccine shall be 36 months from the date of manufacture of the final bulk when stored at ---° C. The date of manufacture shall be defined as the date of initiation of the last valid potency test for the component tested first.

Please submit final bulk samples of the product together with lot release protocols in electronic format showing results of all applicable tests. You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologics Evaluation and Research (CBER).

You must submit information to your BLA for our review and written approval under 21 CFR 601.12 for any changes in the manufacturing, testing, packaging or labeling of Boostrix vaccine, or in the manufacturing facilities.

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 waiver of your pediatric studies for Boostrix for children 7-9 years of age is justified because such studies are highly impractical and because the number of eligible patients in that age group is small and geographically dispersed. In addition, we agree that a waiver of your pediatric studies for Boostrix for children less than 7 years of age is applicable because Boostrix does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients in this age group.

Postmarketing Studies subject to reporting requirements of 21 CFR 601.70.

We acknowledge the post-marketing clinical commitments outlined in your submissions of April 22, 26, and 28, 2005, as follows:

  1. To conduct a randomized, partially blinded, comparative study evaluating safety and immunogenicity when Boostrix vaccine is given concomitantly with Menactra. The study will be conducted in approximately 1,335 adolescents aged 11-18 years. The final study protocol will be submitted by October 31, 2005. The study will be initiated no later than February 28, 2006. The final study report will be submitted by September 30, 2008.
  2. To submit a supplement to your license to include data from a study in which subjects received Boostrix following five doses of Infanrix in childhood. This supplement will be submitted by June 30, 2005.
  3. To conduct an open label, safety surveillance study that evaluates at least 10,000 subjects. The final study protocol will be submitted by November 30, 2005. The study will be initiated by February 28, 2006 and it will be completed by June 30, 2007. The final study report will be submitted by June 30, 2008.

Postmarketing Studies not subject to reporting requirements of 21 CFR 601.70.

We acknowledge the post-marketing non-clinical commitments outlined in your submissions of April 28, and April 29, 2005, as follows:

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We request that you submit clinical protocols to your IND, with a cross-reference letter to this biologics license application (BLA), STN BL 125106. Submit nonclinical and chemistry, manufacturing, and controls protocols and all study final reports to your BLA, STN BL 125106. Please use the following designators to label prominently all submissions, including supplements, relating to these postmarketing study commitments, as appropriate:

  • Postmarketing Study Protocol
  • Postmarketing Study Final Report
  • Postmarketing Study Correspondence
  • Annual Report on Postmarketing Studies

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. 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 subject 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/cder/pmc/default.htm). Please refer to the April 2001 Draft 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/cber/gdlns/post040401.htm) for further information.

Please submit adverse experience reports in accordance with the adverse experience reporting requirements for licensed biological products (21 CFR 600.80), and distribution reports as described in (21 CFR 600.81). Under 21 CFR 600.80(c)(2) [Periodic Adverse Experience Reports], you must report each adverse experience not reported under paragraph (c)(1)(i) of this section at quarterly intervals for the first 3 years following approval, and then at annual intervals. Since your product is characterized as a vaccine, submit these reports to the Vaccine Adverse Event Reporting System (VAERS) using the pre-addressed form VAERS-1.

You must submit reports of biological product deviations under 21 CFR 600.14. You should promptly identify and investigate all manufacturing deviations, including those associated with processing, testing, packing, labeling, storage, holding and distribution. If the deviation involves a distributed product, may affect the safety, purity, or potency of the product, and meets the other criteria in the regulation, you must submit a report on Form FDA-3486 to the Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Rockville, MD 20852-1448.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h and FDA Form 2567, as appropriate. 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 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. Two copies of final printed advertising and promotional labeling should be submitted at the time of initial dissemination, accompanied by a FDA Form 2253.

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 submitted data to support such claims to us and received CBER approval for such claims.

If you have any questions please contact LCDR Edward Wolfgang at 301-827-3070.

Sincerely yours,

--- signature ---

Norman W. Baylor, Ph.D.
Acting Director
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research