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Osteoarthritis injection nearing approval

This article was originally published in The Gray Sheet

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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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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