FDA Clears Zohydro Single-Entity Hydrocodone Without Abuse Deterrence Properties

Advisory committee had recommended against approval before the agency imposed additional post-marketing study requirements on the extended-release/long-acting opioid class.

FDA approved Zogenix Inc.’s Zohydro ER, finding that the single-entity extended-release hydrocodone product, the first to clear the agency, offers an important therapeutic option to treat pain.

A Schedule II controlled substance, Zohydro is indicated for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. The...

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