Published in Health Business Week, August 3rd, 2007
Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Xopenex product with the U.S. Food & Drug Administration (FDA) in March 2007, and received notification of the application's acceptance for filing in May 2007. Following receipt of the notice from the FDA, Barr notified Sepracor, the New Drug Application (NDA) and patent owner.
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