|Date:||October 20, 2009|
|From:||Maryann Gallagher, Consumer Safety Officer|
|Through:||Ele Ibarra-Pratt, RN, MPH, Branch Chief|
|To:||Joseph Temenak, Primary Reviewer, OVRR/DVRPA|
Jennifer Bridgewater, RPM, OVRR/DVRPA/VCTB
Meghan Ferris, MD, OVRR/DVRPA/VCTB
|Subject:||Review of Proposed Container and Package Labeling|
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine
BLA STN 125363
The Advertising and Promotional Labeling Branch (APLB) reviewed the proposed container and package labeling for MENHIBRIX Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine submitted on August 12, 2009, to BLA STN 125363.
APLB has the following comments:
We recommend including the indicated age group i.e., “For 6 weeks through 15 months of age” and the route of administration, with sufficient prominence to help reduce confusion with Menomune and Menactra.
If you have any questions, please contact Maryann Gallagher at 301-827-6330.