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Elite's Opioid Carries Risk Of Overdose After Heavy Meal, FDA Says

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Executive Summary

Complete response letter explains that SequestOx labeling could not adequately mitigate the risk; firm to propose another bioequivalence study in patients receiving drug after eating fatty food.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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