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Mar 25, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Zohydro ER hydrocodone bitartrate regulatory update

In February, Zogenix said FDA delayed its decision on an NDA for Zohydro ER hydrocodone bitartrate to manage moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. FDA did not provide a specific reason for the delay. The company said FDA indicated that "the delay would be brief and may last only several weeks." The oral controlled-release formulation of hydrocodone had a March 1 PDUFA date. In December, an FDA panel voted 11-2, with 1 abstention,...

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