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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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October 23, 2009 Approval Letter - Ixiaro

October 23, 2009

Our STN:  BL 125280/9

Intercell USA, Inc.  
Attention:  Paul J. Wilson
179 Castles Gate Drive
Mooresville, NC  28117

Dear Mr. Wilson:

We have approved your request to supplement your biologics license application for Japanese Encephalitis Virus, Vaccine, Inactivated, Adsorbed, to include revisions to the military version of 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.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,


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