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Anika Therapeutics, Inc.
Cingal is a second-generation version of Anika's own Monovisc. It is similar to Monovisc except that it contains an active anti-inflammatory component, specifically triamcinolone hexacetonide.
As of December 2015, the U.S. Food & Drug Administration's (FDA) Office of Combination Products has assigned CINGAL to the Center for Drug Evaluation and Research (CDER) as the lead center for premarket review.
Outside the U.S., Cingal is approved as a device. In the European Economic Area and other parts of the world, Cingal is indicated as a viscoelastic supplement or a replacement for synovial fluid in human joints. In Canada, Cingal is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g. acetaminophen).
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