April 22, 2010 –Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
NDA – ACUROX (Acura)
Agenda: On April 22, 2010, the committees will discuss new drug application (NDA) 22-451 ACUROX (oxycodone HCl and niacin) Tablets, Acura Pharmaceuticals, Inc., for the proposed indication of relief of moderate to severe pain where the use of an immediate-release, orally administered, opioid analgesic tablet is appropriate, and the results of studies evaluating the addition of niacin, added for the purpose of reducing the misuse of oxycodone.
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