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Acurox Approval Could Be Impossible Given Combination Drug Regs

Executive Summary

By determining that the niacin component of King Pharmaceuticals/Acura Pharmaceuticals' Acurox, an abuse-resistant formulation of immediate-release oxycodone, is ineffective at deterring oral abuse of the opioid product, an FDA advisory committee may have precluded the possibility of approval, given the regulations governing combination products

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