Published on September 4, 2009 at 12:48 AM
Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) and King Pharmaceuticals, Inc. (NYSE: KG) announced today that they met with the U.S. Food and Drug Administration ("FDA") on September 2, 2009 to discuss the FDA’s June 30, 2009 Complete Response Letter regarding the New Drug Application for Acurox® (oxycodone HCl and niacin) Tablets CII (NDA).
The FDA and the Companies agreed to take the NDA to an FDA Advisory Committee to consider the evidence to support the potential opioid abuse deterrent effects of Acurox® Tablets. The FDA indicated that no new clinical trials are required at this time. The FDA has not yet set a meeting date for the Advisory Committee’s review of the NDA. The Companies do not expect the meeting to be convened before the end of this year.
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