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Osteoarthritis injection nearing approval

This article was originally published in The Gray Sheet

Executive Summary

Savient Pharmaceuticals receives "approvable" letter for its sodium hyaluronate injection product for the treatment of pain associated with knee osteoarthritis. Unresolved issues include an audit of a new manufacturing facility in Israel and finalization of labeling. Savient reacquired worldwide rights to the product from J&J subsidiary DePuy Orthopaedics Sept. 25. The viscosupplementation product is marketed as Arthrease in Europe...
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