GENZYME CARTICEL BLA APPROVAL WILL BOOST INSURANCE COVERAGE, PRODUCT SALES, COMPANY SAYS; FDA REQUIRES POSTMARKET STUDIES TO EVALUATE LONG-TERM EFFICACY
This article was originally published in The Gray Sheet
Executive Summary
FDA approval of Genzyme Tissue Repair's Carticel knee cartilage repair product on Aug. 25 is expected to result in an increased in insurance coverage and higher sales, the company says. Agency sign-off on a biological license application for Carticel for the repair of cartilage defects of the knee made it the first such product to receive formal approval.
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