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News Breaks
December 7, 2012
17:49 EDTZGNXZogenix announces FDA panel votes against approval of Zohydro ER
Zogenix announced that the U.S. Food and Drug Administration's Anesthetic and Analgesic Drug Products Advisory Committee voted 2-11 against the approval of Zohydro ER, an extended-release formulation of hydrocodone without acetaminophen, 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. "We remain confident in the measures we have proposed to support safe use of Zohydro ER and are committed to continuing to work with the FDA through the review process to bring this treatment option to this specific patient population," Zogenix COO Stephen Farr said. The Prescription Drug User Fee Act date for completion of FDA review of the Zohydro ER New Drug Application for approval is March 1, 2013.
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September 2, 2014
08:56 EDTZGNXOn The Fly: Pre-market Movers
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07:31 EDTZGNXZogenix Zohydro ER demonstrates sustained 12-hour pain relief
Zogenix announced new post-hoc analysis data showing that the indicated 12-hour dose of Zohydro ER, Extended-Release Capsules, CII, provided durable pain relief over the entire dosing interval. This finding is important because a major concern for all extended-release pain medications is the potential for lack of consistent pain relief throughout the entire day, especially at the end of the dosing.
August 25, 2014
17:15 EDTZGNXArmistice Capital reports 5.9% passive stake in Zogenix
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