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Vaccines, Blood & Biologics

March 12, 2012 Approval Letter - Infanrix

GlaxoSmithKline Biologicals
Attention: Patrick J. Thomas
2301 Renaissance Boulevard
P.O. Box 61540
King of Prussia, PA19406-2772

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

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