Barr Pharmaceuticals, Inc. said its subsidiary, Barr Laboratories, Inc., received final approval from the US Food & Drug Administration (FDA) for its application to manufacture and market a generic version of Forest Pharmaceuticals, Inc's pain medication Combunox.
The approval followed the expiration of the new combination exclusivity period for Combunox. The company plans to launch its product immediately.
Combunox (oxycodone HCl and ibuprofen) 5mg/400mg tablets are indicated for the short term (no more than 7 days) management of acute, moderate to severe pain. The product had annual sales of approximately $4 million for the twelve months ended September 2007, based on IMS sales data.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidiaries. The Barr Group of companies markets more than 115 generic and 25 proprietary products in the US and more than 1,200 products globally outside of the US.