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Carol Eustice

Zohydro ER (Extended-Release Hydrocodone) Approved by FDA

By October 25, 2013

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On October 25, 2013, the U.S. Food and Drug Administration announced the approval of Zohydro ER (hydrocodone bitartrate extended-release capsules) for pain severe enough to require daily, around-the-clock, long-term treatment which is inadequately relieved with other treatment options. Zohydro ER is a Schedule II controlled substance. The drug is the first FDA-approved single entity (i.e., not combined with another analgesic ingredient such as acetaminophen), extended-release formulation of hydrocodone.

Zohydro ER labeling meets the requirements of extended-release, long-acting (ER/LA) opioids announced on September 10, 2013. The FDA will require postmarketing studies of Zohydro ER to evaluate known risks when used longer than 12 weeks. The approval of Zohydro ER will provide another option for arthritis patients who struggle to find satisfactory pain relief.

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