FDA OKs Abuse-Deterrent Opioid, Minus Some Label Claims

Law360, New York (January 10, 2017, 4:41 PM EST) -- The U.S. Food and Drug Administration on Monday approved a long-term opioid painkiller made by Egalet Corp. and signed off on label claims that the drug can deter abuse if it is dissolved and injected, but not if it is snorted or chewed, as had been recommended by an advisory panel.

An advisory panel in August voted 18-1 to recommend approving Arymo ER extended release tablets to treat pain serious enough to require round-the-clock treatment that can’t be addressed by alternative options. It also recommended labeling...
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