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News Breaks | | | | December 7, 2012 | | 17:49 EDT |  | ZGNX | Zogenix 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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