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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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March 12, 2012 Approval Letter - Infanrix


GlaxoSmithKline Biologicals
Attention:  Patrick J. Thomas            
2301 Renaissance Boulevard
P.O. Box 61540
King of Prussia, PA 19406-2772
Dear Mr. Thomas:
We have approved your request to supplement your biologics license applications, for the following supplements, to include changes to the package insert to include "syncope" to the Warnings and Precaution section in Highlights and the Full Prescribing Information:
103239/5348 - Hepatitis B Vaccine (Recombinant) (ENGERIX-B)
103475/5370 - Hepatitis A Vaccine Inactivated (HAVRIX)
103850/5488 - Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine (TWINRIX)
103647/5308 - Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed (INFANRIX)
103907/5516 - DTaP & Hepatitis B (Recombinant) & Inactivated Polio Virus Vaccine (PEDIARIX)
125347/149 - Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) (HIBERIX)
125260/273 - Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed and Inactivated Poliovirus Vaccine (KINRIX)
125127/495 - Influenza Virus Vaccine (FLUARIX)
125106/813 - Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX)
We will include information contained in the above-referenced supplement in your biologics license application file.
Sincerely yours,
                                                                        Wellington Sun, M.D.
                                                                        Division of Vaccines and
                                                                          Related Products Applications                                                    
                                                                        Office of Vaccines
                                                                          Research and Review
                                                                        Center for Biologics
                                                                         Evaluation and Research
Attachment: Approved Final Draft Labeling