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Arthritis Blog

By Carol & Richard Eustice, About.com Guides to Arthritis since 1997

Synvisc-One Recommended for FDA Approval

Wednesday December 17, 2008
Synvisc-One, a single injection version of Genzyme's Synvisc, has been recommended for approval by the FDA Orthopaedic and Rehabilitation Devices Panel. The original formulation of Synvisc -- approved in the U.S. in 1997 to treat knee osteoarthritis in patients who failed conservative non-drug treatments and the use of simple analgesics -- is administered as a series of 3 intra-articular injections. In Europe and Canada, Synvisc is approved for the treatment other joints -- not just the knee.

Synvisc and Synvisc-One are viscosupplements. The procedure, known as viscosupplementation, involves injecting hyaluronic acid into the joint to act as a lubricant and shock absorber. Synvisc-One was approved in the European Union and several Asian and Latin American countries last year. The FDA is expected to make a final decision on the approval of Synvisc-One on December 23, 2008.

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