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Going Around in Circles

This article was originally published in RPM Report

Executive Summary

Early on in the committee discussion of Acurox, FDA made its feelings about the product clear. Here is a transcript of the exchange between two committee members and two FDA officials on the key question about the King application: what exactly should be required to allow inclusion of niacin in the formulation with the goal of provoking adverse effects in abusers of immediate release oxycodone.

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