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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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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

--signature--
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

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Food and Drug Administration

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Silver Spring, MD 20993-0002