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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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October 8, 2009 Approval Letter

October 8, 2009

Our STN:  BL 102821/5085

Organon Teknika Corporation LLC
Attention: Ed Nellis
100 Rodolphe Street
Building 1300
Durham, NC  27712

Dear Mr. Nellis:

We have approved your request to supplement your biologics license application for BCG Live, to include a reconstitution accessory kit as a second option for reconstitution.

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

Sincerely yours,

 

Milan S. Blake, Ph.D.
Director
Division of Bacterial, Parasitic and 
Allergenic Products 
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research

 

Attachment: Approved Final Draft Labeling