Opioid Abuse Deterrence: Purdue Expects Quick Results On OxyContin, But Cmte. Wonders About Duration Of Effect
This article was originally published in The Pink Sheet Daily
Executive SummaryThe surveillance system for tracking adverse events associated with the reformulated drug continues to evolve, the firm tells an FDA advisory panel.
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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.