Zogenix, Inc. Announces FDA Acceptance for Review of Zohydro ER(TM) New Drug Application (NDA) for Treatment of Chronic Pain
Published: Jul 16, 2012
SAN DIEGO, July 16, 2012 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, announced today that the U.S. Food and Drug Administration (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.