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Vaccines, Blood & Biologics

March 2, 2000 Approval Letter

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

March 2, 2000

Our Reference No. 99-1262

Mr. Russell Hemdon
Genzyme Tissue Repair
64 Sidney Street
Cambridge, MA 02139-4136

Dear Mr. Herndon:

Your request to supplement your biologics license application for Autologous Cultured Chondrocytes 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, has been approved.

We acknowledge your written commitment to implement use of the revised labeling, and issue the Dear Doctor Letter announcing this narrowed indication, by March 10, 2000.

Your request to modify your post-marketing studies, committed to as a condition of approval on August 22, 1997, is currently under review under our reference number 99-1297.

Please submit final printed labeling at the time of use and include implementation information on FDA Form 2567. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels).

This information will be included in your biologics license application file.

Sincerely yours,

--- signature ---

Karen D. Weiss, M.D.
Director
Division of Clinical Trial Design and Analysis
Office of Therapeutics Research and Review
Center for Biologics Evaluation and Research

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