FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties

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Title: FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties

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FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties

11/20/2014 12:54 PM EST

The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Hysingla ER has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.

 

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