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Endo Sees Regulatory Setting For Opana ER As "A Moving Target"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The “complete response” letter for the crush-resistant formulation of Endo Pharmaceuticals’ chronic pain drug Opana ER (oxymorphone) is not surprising, given that FDA has yet to settle on a risk management approach for extended-release opioids.

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