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
Through: Ele Ibarra-Pratt, RN, MPH, Branch Chief
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.