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ARTICLE | Company News

Acura, King get Acurox complete response

July 3, 2009 12:45 AM UTC

Acura Pharmaceuticals Inc. (NASDAQ:ACUR) and King Pharmaceuticals Inc. (NYSE:KG) said FDA issued a complete response letter for an NDA for Acurox oxycodone/niacin tablets to treat moderate to severe pain. The companies said FDA raised issues about the potential abuse deterrent benefits of Acurox, but that they should be able to respond without conducting additional studies. Last week, the companies said they did not expect the agency to approve Acurox by the June 30 PDUFA date. ...