Vaccines, Blood & Biologics

February 12, 2008 Approval Letter - YF-Vax

February 12, 2008

Our STN: BL 103915/5086

Sanofi Pasteur, Inc.
Attention: Gary Chikami, M.D.
Discovery Drive
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:

  1. CONTRAINDICATIONS: addition of postponement of vaccinations in case of an acute febrile disease.
  2. PRECAUTIONS, Pregnancy Category C: changes in statements for use of the vaccine in pregnant women.
  3. PRECAUTIONS, Nursing Mothers: changes in statement for use of the vaccine during lactation.
  4. 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.

Sincerely yours

Loris D. McVittie, Ph.D.
Acting Chief
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

Attachment: Approved Final Draft Labeling

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 02/16/2010
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