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news.Barr Laboratories has received final approval from the FDA for its application to manufacture and market oxycodone HCl and ibuprofen tablets, 5mg/400mg, indicated for the short-term management of acute, moderate to severe pain.
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Oxycodone HCl and ibuprofen tablet is a generic version of Forest Pharmaceuticals’s Combunox. The approval came following the expiration of the new combination exclusivity period for Combunox.
The company plans to launch its product immediately. The product had annual sales of approximately $4 million for the 12 months ended September 2007, based on IMS sales data.