Genzyme Corporation has received European approval to expand the CE Mark labeling for hylan G-F 20 (Synvisc) to include the treatment of pain resulting from osteoarthritis (OA) of the ankle and shoulder. The CE Mark is mandatory for 70% of the products sold in Europe.
Synvisc is sold in more than 60 countries and is approved in the U.S. to treat pain resulting from OA of the knee. The approval of the new indication was based on prospective, multicenter, open investigations in Europe. Treatment with one or two injections was well tolerated.
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As a nonsystemic treatment, Synvisc helps avoid some of the side effects associated with some nonsteroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors.
Genzyme is pursuing a label expansion in the U.S. that would include an indication for the hip.