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U.S. Department of Health and Human Services

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Vaccines

Review Memorandum - June 22, 2009 - Hiberix

Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality
Division of Case Management
Advertising and Promotional Labeling Branch

 

REVIEW MEMORANDUM

Date:  June 22, 2009

To:   Elisa Harkins
        Associate Director, North American Regulatory Affairs
        GlaxoSmithKline

Through:  Ele Ibarra-Pratt, RN, MPH, Branch Chief
                Advertising and Promotional Labeling Branch (APLB)

From:  Maryann Gallagher, Consumer Safety Officer
         APL

Product:  Hiberix [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)]
              STN# 125347
               Sponsor: GSK


The Advertising and Promotional Labeling Branch (APLB) reviewed the revised proposed product logo that you submitted for advisory comment on June 11, 2009 to the BLA for Hiberix [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)].  We have reviewed the proposed logo and we have no concerns at this time. 

If you have any questions, please contact Maryann Gallagher, Consumer Safety Officer at 301-827-3028.