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December 20, 2012
08:17 EDTACURAcura Pharma submits Investigational NDA
Acura Pharmaceuticals announced that an Investigational New Drug application, or IND, has been filed with the FDA to allow clinical testing of Acura's hydrocodone bitartrate with acetaminophen formulated with Aversion Technology. Clinical testing can commence under the IND 30 days following the IND filing unless questions are raised by the FDA. An open IND is required for Acura to initiate intranasal abuse liability testing in recreational drug users of the crushed drug product.
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