December 22, 2009 Approval Letter - Pentacel
December 22, 2009
Our STN: BL 125145/88
Sanofi Pasteur Limited
Attention: Joseph H. Quinn
1755 Steeles Avenue West
Toronto, Ontario July 13, 2009
Canada M2R 3T4
Dear Mr. Quinn:
We have approved your request to supplement your biologics license application for Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine to revise the labeling to comply with the Physician’s Labeling Rule format.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please 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 to support that claim.
We will include information contained in the above-referenced supplement in your biologics license application file.
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeling