FDA approves first single-entity, extended-release hydrocodone drug

Agency announces approval of Zogenix's Zohydro ER

SILVER SPRING, Md. — The Food and Drug Administration has approved a new opioid painkiller made by Zogenix, the agency said Friday.

The FDA announced the approval of Zohydro ER (hydrocodone) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term treatment. The agency said the drug was the first extended-release hydrocodone product not combined with another drug, such as acetaminophen, to be approved by the agency.

Because it is a so-called single-entity hydrocodone product, Zohydro ER is listed as a Schedule II controlled substance. Drugs that combine no more than 15 mg of hydrocodone with another analgesic, such as AbbVie's Vicodin, are Schedule III drugs, though the FDA said this week that it would recommend those products for CII scheduling as well.


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