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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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March 12, 2012 Approval Letter- ENGERIX-B

 

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.
                                                                        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