DEPARTMENT OF HEALTH AND HUMAN SERVICES
PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
DATE: January 8, 2008
FROM: Daphne Stewart-Bennett, CSO,
Division of Vaccines and Related Products Applications,
THROUGH: Joseph J. Temenak, Director, Regulatory Review Officer, BVAPB
TO: BLA STN 125260/0 File
SUBJECT: Review of GlaxoSmithKline Biologicals, BLA 125260/0
Diphtheria and Tetanus Toxoids, Acellular Pertussis Vaccine Adsorbed and Poliovirus Vaccine Inactivated Combined - Labeling
GlaxoSmithKline Biologicals has submitted a Biologic License Application for Diphtheria and Tetanus Toxoids, Acellular Pertussis Vaccine Adsorbed and Poliovirus Vaccine Inactivated Combined Labeling. The purpose of this application is for the active immunization against diphtheria, tetanus, pertussis and poliomyelitis.
GlaxoSmithKline Biologicals has provided labeling for their package insert (PI), container and carton labels.
I recommend revising the statement "Novartis Vaccines and Diagnostics" on the last section to "Novartis Vaccines and Diagnostics GmbH & Co. KG" as this is the sponsor's legal sponsor name.
I recommend approval without the "Rx Only" statement since it complies with 21 CFR 610.60 (c) as a partial label. This will be consistent with their previous (Twinrix and Engerix) labels of this type.
I recommend approval with the statement "Preservative Free" instead of the "No Preservative" on the front panel as in compliance with the 21 CFR 610.61 (e), since it does not take away from the meaning of the statement. This will be consistent with their previous (Twinrix and Engerix) labels of this type.
Therefore, I have determined that the container and carton labels are acceptable,and request that the sponsor make the recommended minor change to the package insert.
Daphne Stewart-Bennett, CSO