October 8, 2009
Our STN: BL 102821/5085
Organon Teknika Corporation LLC
Attention: Ed Nellis
100 Rodolphe Street
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.
Milan S. Blake, Ph.D.
Division of Bacterial, Parasitic and
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeling