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| | | ![]() Treatment For Knee Osteoarthritis To Be Available In U.S. RIDGEFIELD, N.J. -- August 13, 1997 -- The Food and Drug Administration (FDA) has granted approval to Biomatrix, Inc. to market Synvisc, the company’s new treatment for knee pain due to osteoarthritis. This approval represents the culmination of 10 years of global clinical research and post-marketing studies in Europe, Canada and the United States. Synvisc is an intra-articular treatmentfor osteoarthritis of the knee, a painful and debilitating joint disease that affects nearly 16 million Americans in which the elastoviscous properties of the synovial fluid in the knee joint diminish, resulting in less protection and shock absorption. It is used for patients who do not get adequate relief from simple painkillers (e.g., acetaminophen) or from exercise and physical therapy. Clinical studies have shown that patients with osteoarthritic pain, who had not obtained pain relief with other medications, experienced pain relief from Synvisc injections into the knee joint. Synvisc will be available for sale by or on the order of a physician (or properly licensed practitioner), and is administered once per week for a total of three intra-articular injections during a two-week period. Wyeth-Ayerst Laboratories, a division of American Home Products Corporation, has a marketing and distribution agreement with Biomatrix to sell Synvisc in the United States. Biomatrix will manufacture the product for sale by Wyeth-Ayerst, and expects Synvisc to be available in the United States this fall. Synvisc has also been approved for marketing in the European Economic Area, Canada and China, and is currently being manufactured by Biomatrix and sold in Europe and in Canada through marketing and distribution agreements with a number of large multi-national pharmaceutical companies including Boehringer Ingelheim, Hoffmann La Roche, and Rhone-Poulenc Rorer. In addition to the United States, Wyeth-Ayerst will market Synvisc in Germany, Austria, Spain, Portugal, Greece and certain countries in the Middle East and Central Europe. Biomatrix also has a marketing agreement with Bayer AG to market Synvisc in Australia, New Zealand, Taiwan, Singapore, Indonesia, Thailand, Malaysia and Israel. More information on: Biomatrix, Synvisc, Wyeth-Ayerst
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