The FDA has granted a Premarket Approval Application (PMA) for 1% sodium hyaluronate (Nuflexxa™, Savi-ent Pharmaceuticals, Inc.).
Nuflexxa™ is indicated for the treatment of pain in osteoarthritis of the knee in patients who have not responded adequately to conservative nonpharmaco-logical therapy or simple analgesics . The product has been approved in Europe as Euflexxa™.
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This is the only non-avian-derived hyaluronic acid approved in the U.S. It is a product of Bio-Technology General (Israel) Ltd., a Savient subsidiary.