Synvisc-One Recommended for FDA Approval
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.
Related Resources:
- What Is Viscosupplementation?
- 25 Effective Osteoarthritis Treatments
- 16 Non-drug Treatments for Osteoarthritis
- Any Joint Can Be Affected By Osteoarthritis
- Hyaluronan Injections for Knee Osteoarthritis
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Photo by Maksim Tselishchev (iStockphoto)


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