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Vaccines, Blood & Biologics

Review of Proposed Container and Package Labeling - May 13, 2009 - Hiberix



MEMORANDUM                           Department of Health and Human Services
                                               Public Health Service
                                               Food and Drug Administration
                                              Center for Biologics Evaluation and Research


Date:  May 13, 2009

From:  Maryann Gallagher, Consumer Safety Officer
           OCBQ/DCM/APLB, HFM-602

Through:    Ele Ibarra-Pratt, RN, MPH, Branch Chief
                  OCBQ/DCM/APLB, HFM-602 

To:  Jason Humbert, RPM, OVRR/DVRPA/CMC1, HFM-481
         Jay Slater, M.D, Chairperson, OVRR/DBPAP/LRSP, HFM-437
          Karen Farizo, MD, Medical Officer, OVRR/DVRPA/VCTB, HFM-475

Subject: Review of Proposed Container and Package Labeling

Product:  Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)]

                 Sponsor: Glaxo SmithKline

The Advertising and Promotional Labeling Branch (APLB) reviewed the proposed container and package labeling submitted on March 17, 2009 with the BLA for Hiberix [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)].  Please ensure that the final packaging for Hiberix is distinct from Havrix and the other Haemophilus vaccines to avoid confusion and medication errors. 

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


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