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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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October 8, 2009 Approval Letter - Kinrix

October 8, 2009

OUR STN:  BL  125260/140

GlaxoSmithKline Biologicals
Attention: Michael S. VanDerWerf
2301 Renaissance Boulevard
Building 510

King of Prussia, PA 19406-2772

Dear Mr. VanDerWerf:

We have approved your request to supplement your biologics license application for Diphtheria and Tetanus Toxoids, Acellular Pertussis Vaccine Adsorbed and Poliovirus Vaccine Inactivated Combined, to include changes to your package insert to the Dosage and Administration section regarding visual inspection by the user for cracked vials or syringes prior to administration of the vaccine and non-use of product should those conditions exist.

Please submit all final printed labeling and implementation information on Form FDA 356h and FDA form2567 as appropriate.  Please provide content of labeling in Structured Product Labeling format. 

We will include the information contained in the above-reference 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 Draft Labeling