Acura Pharmaceuticals, a specialty pharmaceutical company, has submitted a briefing package to the FDA addressing the issues raised in the FDA's June 30, 2009 complete response letter related to the new drug application for Acurox tablets.
Acura and King Pharmaceuticals R&D, are scheduled to meet with the FDA in late third quarter 2009 to discuss the complete response letter and the briefing package.
According to Acura, Acurox is an immediate release tablet with a proposed indication for the relief of moderate-to-severe pain. Acurox incorporates Acura's Aversion technology and is intended to discourage product misuse and abuse.
Acura and King, its exclusive licensee in the US, Canada and Mexico, are developing Acurox and three additional opioid analgesic products utilizing Aversion technology.
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