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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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December 4, 2008 Approval Letter - Boostrix

December 4, 2008

Our STN: BL 125106/298

GlaxoSmithKline Biologicals
Attention: Ms. Donna Boyce
2301 Renaissance Blvd. Building- 510
P.O. Box 61540
King of Prussia , PA 19406-2772

Dear Ms. Donna Boyce:

We have approved your request to supplement your biologics license application (BLA) for Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (BOOSTRIX ®), to include single booster dose in adults 19-64 years of age for active immunization against tetanus, diphtheria, and pertussis. This approval includes an updated package insert that complies with the physicians labeling rule format.

Under 21 CFR 201.57(c) (18), patient labeling must be reprinted at the end of the package insert and printed in a minimum of 10-point font.

Please submit all final printed labeling and implementation information on FDA Form 356h. Please provide a PDF-format electronic copy. 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. 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 to support that claim.

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

Sincerely yours,

-signature-

Wellington Sun, M.D.
Director
Division of Vaccines and
  Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Attachment: Approved Draft Labeling