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Zogenix Zohydro Launch Will Test FDA’s Balanced Approach On Opioid Pain Reviews

This article was originally published in RPM Report

Executive Summary

FDA approved Zogenix’ single-entity hydrocodone product following a negative advisory committee meeting, and is facing ongoing opposition as the drug’s launch begins. The agency argues the risk is consistent with other extended-release opioids – and abuse-deterrent technology is too new to require.

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