| NDA submitted for Acurox |
| Written by General Motors Corp. | |||||||
| Friday, 02 January 2009 | |||||||
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Acura Pharmaceuticals, Inc. submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting a priority review for Acurox(r) (oxycodone HCl/niacin) Tablets, as announced by Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. The FDA will determine whether to accept the NDA for filing and consider the priority review request within 60 days.
Acura and King believe Acurox(r), if approved will be the first FDA approved immediate release opioid analgesic designed to deter swallowing excess quantities of tablets and other common methods of misuse and abuse.
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