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No Abuse-Resistance Claim For Endo’s Opana ER Reformulation

This article was originally published in The Pink Sheet Daily

Executive Summary

Endo’s Opana ER reformulation, which uses proprietary technology to deter crushing, receives approval but no labeling language on crush-resistance or abuse deterrence, according to FDA. The company says a U.S. patent to be issued Dec. 13 will protect the new formulation until November 2023.


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