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November 8, 2012
09:37 EDTZGNXZogenix announces FDA Advisory Committee to review Zohydro ER NDA on Dec. 7
Zogenix announced that the U.S. FDA Anesthetic and Analgesic Drug Products Advisory Committee, or AADPAC, will review the company's New Drug Application, or NDA, for Zohydro ER -- hydrocodone bitartrate extended-release capsules -- on Dec. 7, 2012. Zohydro ER is Zogenix's lead investigational product candidate for the management of moderate-to-severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Details of the meeting agenda will be available in the Federal Register. The Prescription Drug User Fee Act, or PDUFA, date for completion of the review by the FDA is March 1, 2013. If approved, Zohydro ER will be classified as a Drug Enforcement Agency, or DEA, Schedule II drug, subject to stricter prescribing and dispensing rules compared to the currently prescribed hydrocodone products.
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August 25, 2014
17:15 EDTZGNXArmistice Capital reports 5.9% passive stake in Zogenix
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