Product Approval Information - Licensing Action
June 21, 2007
Our STN: BL 103661/5155
Attn: Laura Mondano
Genzyme Biosurgery
55 Cambridge Parkway
Cambridge, MA 02142
Dear Ms. Mondano:
We have approved your request to supplement your biologics license application for Autologous Cultured Chondrocytes to revise the Package Insert to include safety and efficacy data from the Study of the Treatment of Articular Repair; and formatting and content changes in compliance with the Physician's Labeling Rule.
This fulfills your commitment to conduct a prospective, longitudinal, multi-center study (#012-99) of 100 subjects with articular cartilage defects of the medial or lateral condyles, or trochlea having inadequate response to prior non-Carticel surgical treatment (including marrow stimulation techniques, transplantation of cells or tissues, or debridement followed by an adequate rehabilitation program, but not including lavage, biopsy or diagnostic arthroscopy) as stated in commitment number 2 of the April 28, 2000 approval letter.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels). In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, MD 20852-1448. Please submit your final printed advertising and promotional labeling at the time of initial dissemination, accompanied by an FDA Form 2253.
We will include information contained in the above-referenced supplement in your biologics license application file.
Sincerely yours,
--- signature ---
Ashok Batra, M.D.
Director
Division of Clinical Evaluation and Pharmacology/Toxicology
Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research