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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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January 28, 2010 Approval Letter - YF Vax

Our STN:  BL 103915/5114

Sanofi Pasteur Inc.
Attention:  Joseph H. Quinn 
Discovery Drive
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.  

Sincerely yours,

--signature--

Wellington Sun, M.D.
Director
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