Panel Meeting Durolane™ August 19th 2009
Q-Med’s Premarket Approval (PMA) application for Durolane™ in the US will be discussed on August 19th 2009, at a public meeting of the FDA's Orthopaedic and Rehabilitation Devices Advisory Committee. The panel is expected to consider the clinical trial results Q-Med submitted to support the approval and labeling of Durolane, a single dose product indicated for the treatment of pain caused by osteoarthritis of the knee.