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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Review of Proposed Container and Package Labeling - July 14, 2009 - Hiberix

 

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


 Date:  July 14, 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)
               BLA STN 125347

Sponsor:  GSK

The Advertising and Promotional Labeling Branch (APLB) reviewed the proposed container and package labeling submitted on July 10, 2009, to the Hiberix BLA STN 125347 for Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid).  APLB has no comments at this time.

If you have any questions, please contact Maryann Gallagher at 301-827-6330.