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Briefing docs suggest supportive, lively adcom for Kempharm's Apadaz

By Michael Fitzhugh
Staff Writer

Wednesday, May 4, 2016

Briefing documents prepared for FDA advisors considering potential approval of Kempharm Inc.'s abuse-deterrent prodrug of hydrocodone, Apadaz (KP-201/acetaminophen), on Thursday appeared supportive of the 505(b)(2) filing, while simultaneously acknowledging the complexity of making recommendations on the drug's label in light of the critical public health issues on the road to safer opioid analgesics.

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