Aplisol September 23, 2008 Approval Letter
September 23, 2008
OUR STN: BL 103782/5068
JHP Pharmaceuticals, LLC
Attention: Carla English
One Upper Pond Road
Building D, 3rd Floor
Parsippany, NJ 07054
Dear Ms. English:
We have approved your request to supplement your biologics license application for Tuberculin, Purified Protein Derivative, to include revisions to the package insert.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide this labeling as a PDF-format electronic copy.
We will include information contained in the above-referenced supplement in your biologics license applications file.
/Wellington Sun, M.D./
Wellington Sun, M.D.
Division of Bacterial, Parasitic and Allergenic Products
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research
Attachment: Approved Final Draft Labeli