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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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December 16, 2010 Approval Letter - BCG Live (TICE® BCG) and BCG Vaccine

Our STNs: BL 102821/5105, 103050/5077

Organon Teknika Corporation, LLC
Attention: Dr. Lawrence Starke, Ph.D.
100 Rodolphe St.
Building 1300
Durham, NC 27712

Dear Dr. Starke:

We have approved your request to supplement your biologics license applications for BCG Live (TICE® BCG) and BCG Vaccine to include revisions to your post-marketing routine stability study protocol.

Under this approval, you will eliminate the 15 month stability time point and the ---------------------b(4)----------------------- performed at the remaining T0, 6, and 12 months stability time points. In addition, you will add a sterility test to the 12 month stability time point.      

We will include information contained in the above-referenced supplements in your biologics license applications files.

Sincerely,
 

 

Jay E. Slater, Ph.D.
Acting Director
Division of Bacterial, Parasitic
and Allergenic Products
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research