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[bigcat2]

ZGNX - FDA Advisory Committee
http://finance.yahoo.com/news/zogenix-announces-fda-advisory-committee-142500085.html

SAN DIEGO, Nov. 8, 2012 (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 the U.S. Food and Drug Administration's (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) will review the Company's New Drug Application (NDA) for Zohydro(TM) ER (hydrocodone bitartrate extended-release capsules) on December 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 (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 (DEA) Schedule II drug, subject to stricter prescribing and dispensing rules compared to the currently prescribed hydrocodone products. Zogenix has included in the NDA a comprehensive Risk Evaluation and Mitigation Strategy (REMS) that is consistent with current FDA and industry-wide guidelines for extended-release opioid products. The REMS is intended to control inappropriate prescribing, misuse and abuse of extended-release opioids while maintaining patient access to essential pain medications.