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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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July 25, 2014
08:01 EDTZGNXZogenix price target lowered to $3.50 from $5 at Stifel
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July 23, 2014
16:56 EDTZGNXZogenix competitor gets FDA approval for abuse-deterrent ER oxycodone
The FDA approved Targiniq ER, an extended-release/long-acting opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Targiniq ER is the second ER/LA opioid analgesic with FDA-approved labeling describing the productís abuse-deterrent properties consistent with the FDAís 2013 draft guidance for industry, the FDA stated. The FDA is requiring postmarketing studies of Targiniq ER, to assess the serious risks of misuse, abuse, increased sensitivity to pain, addiction, overdose, and death associated with long term use beyond 12 weeks. The FDA is also requiring postmarketing studies to further assess the effects of the abuse-deterrent features on the risk for abuse of Targiniq ER. In addition, Targiniq ER is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy. Targiniq ER is manufactured by Purdue Pharma. Zogenix has a competing pain killer drug called Zohydro ER.
July 14, 2014
08:36 EDTZGNXZogenix announces patent for DosePro Needle-free Delivery System
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