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Zogenix, Inc. Message Board

  • danritz danritz Feb 26, 2013 8:18 PM Flag

    This can't be good news

    SAN DIEGO, Feb. 26, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, today announced that it has been informed by the U.S. Food and Drug Administration (FDA) that Zogenix is unlikely to receive an action letter for its New Drug Application (NDA) for ZohydroTM ER (hydrocodone bitartrate extended-release capsules) by the Prescription Drug User Fee Act (PDUFA) goal date of March 1, 2013. Under the performance goals set by the FDA under PDUFA, the agency can miss the prescribed goal date for approximately ten percent of the NDAs that are submitted each year and still meet the performance goals for review of priority and standard applications.

    The FDA has not provided Zogenix with information as to the reason for the possible delay, but has indicated that the delay would likely be brief and may last only several weeks. Zogenix has not been informed of any deficiencies in the application during the review process to date.

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