February 12, 2008
Our STN: BL 103915/5086
Sanofi Pasteur, Inc.
Attention: Gary Chikami, M.D.
Swiftwater, PA 18370
Dear Dr. Chikami:
We have approved your request to supplement your Biologics License Application for Yellow Fever Vaccine, to include changes to the package insert as follows:
- CONTRAINDICATIONS: addition of postponement of vaccinations in case of an acute febrile disease.
- PRECAUTIONS, Pregnancy Category C: changes in statements for use of the vaccine in pregnant women.
- PRECAUTIONS, Nursing Mothers: changes in statement for use of the vaccine during lactation.
- ADVERSE REACTIONS: addition of rare neurological symptoms.
Please see attached approved final draft labeling.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy.
We will include the information contained in the above referenced supplement in your Biologics License Application file.
Loris D. McVittie, Ph.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