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  • greatdad100 greatdad100 May 11, 2013 11:05 AM Flag

    This is Why the FDA is Being So Tough on New Abuse Resistant Drug Approvals

    Endo sought a determination from the FDA that the original Opana ER was taken off the market for safety reasons, a determination that would have meant less competition for its newer version. The FDA declined to do so and instead criticized properties of the new Opana ER that were supposed to make the drug resistant to injection and snorting.

    Inconclusive post-marketing studies show the reformulated version may have a higher percentage of abuse via injection than the original version, the FDA said in a statement.

    Sentiment: Hold

 
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