FDA Accepts Review of Zogenix's (ZGNX) Zohydro ER NDA for Chronic Pain
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Zogenix, Inc. (Nasdaq: ZGNX) announced today that the U.S. FDA has accepted for review the New Drug Application (NDA) for Zohydro ER™ (hydrocodone bitartrate extended-release capsules), Zogenix's lead investigational product candidate for the treatment of moderate to severe chronic pain. Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an NDA is 10 months from NDA submission, and the FDA has assigned a target action date of March 1, 2013 for the Zohydro ER NDA.
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