Our STN: 125260/148
Attn: Mr. Michael S. VanDerWerf
2301 Renaissance Boulevard
P.O. Box 61540
King of Prussia, PA 19406-2772
Dear Mr. VanDerWerf:
We have approved your request to supplement your biologics license application for Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine (KINRIXTM)to revise the package insert to include a new presentation of a single-dose prefilled syringe that does not contain latex. The revised package insert includes a unique National Drug Code (NDC) number for the container and package for each approved presentation (single-dose prefilled syringe that does not contain latex, single-dose prefilled syringe that contains latex, and single-dose vial that does not contain latex). The respective NDC number is displayed on the container and package labels.
Please submit all final printed labeling at the time of use and include implementation information on Forms FDA 356h. Provide content of labeling in Structured Product Labeling format.
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence or substantial clinical experience to support that claim.
We will include information contained in the above-referenced supplement in your biologics license application file.
Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccines Research and Review
Center for Biologics
Evaluation and Research
Attachment: Approved Final Draft Labeling