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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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October 1, 2009 Approval Letter

October 1, 2009

Our STN:   BL 103475/5284                     

GlaxoSmithKline Biologicals
Attention: Wendy Valinski
2301 Renaissance Boulevard
P.O. Box 61540
King of Prussia, PA 19406-2772

Dear Ms. Wendy Valinski:

We have approved your request to supplement your biologics license application for Hepatitis A Vaccine Inactivated (Havrix®), to include concomitant administration with Diptheria, Tetanus Toxoids, and Acellular Pertussis Vaccine, Absorbed (Infanrix®) and Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) (ActHIB®) for children 12 to 15 months of age.

This fulfills your commitment to assess the safety and immunogenicity of concurrent administration of HAVRIX® (720 EL.U/0.5 mL dose) with Infanrix and ActHIB in healthy children 12 to 15 months of age as stated in commitment number 4 of the October 17, 2005, approval letter (STN: 103475/5090).

Since this BLA supplement does not contain a new active ingredient, new dosage form, new indication, new route of administration, nor new dosing regimen, there is no requirement for an assessment of the safety and effectiveness in pediatric patients per the Pediatric Research Equity Act.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h.  Please provide content of labeling in Structured Product Labeling format.

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 application file.

Sincerely yours,

 

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 Final Draft Labeling