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
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)
BLA STN 125347
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.