DEPARTMENT OF HEALTH & HUMAN SERVICES
Date: October 23, 2009
From: Daphne D. Stewart-Bennett, CSO
Division of Vaccines and Related Products Applications,
Through: Laraine S. Henchal, Branch Chief, RMSB
To: BLA STN 125363/0 File
Subject Review of GlaxoSmithKline Biologicals, BLA 125363/0
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate
Vaccine – MENHIBRIX®
GlaxoSmithKline Biologicals has submitted a Biologic License Application for Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine – MENHIBRIX® . The purpose of this application is for an active immunization of infants and toddlers 6 weeks
through 15 months of age for the prevention of invasive diseases caused by Neisseria
meningitidis serogroups C and Y and Haemophilus influenzae type b.
GlaxoSmithKline Biologicals has provided labeling for their container, carton, shipper, and package insert labels. I have reviewed all labels except the package insert that will be reviewed by the clinical staff.
The vial labels should be revised to comply with 21 CFR 610.60(2) to include the temperature requirements as well as including the sponsor address and license number. In addition with
21 CFR610.62 (b) the prominence of “Saline Diluent” should be decreased in size.
The container labels should be revised to comply with 610.60(2) (6) to include the sponsor address and license number. Additionally, the sponsor should include 21 CFR 610.62(b) by adding the “Rx Only” statement to the label.
The carton labels should be revised to comply with 610.62(b) the prominence of the point size of the proper name and the trade name of the product.
Furthermore, I agree with Ms. Gallagher’s review dated October 20, 2009, indicating that the age group “For 6 weeks through 15 months of age” and the route of administration, with sufficient prominence to help reduce the confusion with Menomune and Menactra” should be included on all GlaxoSmithKline Biologicals labels for this product for safety issues.
The vial, container, and carton labels need to comply with 21 CFR 610.60 – 610.62.
Therefore, I have determined that these labels need to be revised before they are acceptable for approval.