FDA approves Zohydro ER for management of severe pain

he U.S. Food and Drug Administration approved Zohydro ER for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved single-entity and extended-release hydrocodone product. The approved labeling for Zohydro ER conforms to updated labeling requirements for all ER/LA opioid analgesics announced by the FDA on Sept. 10 and Zohydro ER will be part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy. Zohydro ER is manufactured by Zogenix.