Our STN: BL 103915/5114
Sanofi Pasteur Inc.
Attention: Joseph H. Quinn
Swiftwater, PA 18370
Dear Dr. Quinn:
We have approved your request to supplement your biologics license application for Yellow Fever Vaccine, YF-VAX®, to include the correct description of the appearance of the vaccine after reconstitution with diluent, and to make other minor editorial changes in the package insert.
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 or substantial clinical experience to support such claims
[21 CFR 202.1(e)(6)].
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