Product Approval Information
Proper Name: Autologous Cultured Chondrocytes
Tradename: Carticel
Manufacturer: Genzyme Biosurgery, License #1659
Package Insert (PDF - 143 KB) - June, 2007
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Date: August 22, 1997
Indication: Repair of clinically significant, symptomatic cartilaginous defects of the femoral condyle (medial, lateral or trochlear) caused by acute or repetitive trauma
August 22, 1997 Approval Letter
Summary for Basis of Approval (PDF - 2.3 MB)
FDA Talk Paper
Indication: To narrow the indication to second line therapy, for use in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure
March 2, 2000 Approval Letter Date: February 17, 2004
Processing Change: To utilize the BacT/Alert automated microbial detection system for the release of Carticel product based on interim negative results at approximately day 3 of a 14-day assay
February 17, 2004 Approval Letter Date: June 21, 2007
Revise 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
June 21, 2007 Approval Letter