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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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September 2, 2014
08:56 EDTZGNXOn The Fly: Pre-market Movers
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07:31 EDTZGNXZogenix Zohydro ER demonstrates sustained 12-hour pain relief
Zogenix announced new post-hoc analysis data showing that the indicated 12-hour dose of Zohydro ER, Extended-Release Capsules, CII, provided durable pain relief over the entire dosing interval. This finding is important because a major concern for all extended-release pain medications is the potential for lack of consistent pain relief throughout the entire day, especially at the end of the dosing.

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