Genzyme’s Synvisc-One approved
This article was originally published in The Gray Sheet
Executive Summary
Single-injection viscosupplement is approved to treat osteoarthritis of the knee in patients who have failed to respond to more conservative therapy, the firm announces Feb. 26. On Dec. 9, FDA's Orthopedic and Rehabilitation Devices advisory panel recommended approval of Genzyme's PMA supplement for the single-dose version of Synvisc (approved in 1997). Unlike Synvisc-One, Synvisc requires three intra-articular injections at one-week intervals (1"The Gray Sheet" Dec. 15, 2008, p. 13). Genzyme says it will launch Synvisc-One "immediately.
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