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News Breaks | | | | February 27, 2013 | | 05:04 EDT |  | ZGNX | Zogenix unlikely to receive action letter from FDA for Zohydro NDA by PDUFA goal
Zogenix announced that it has been informed by the FDA that Zogenix is unlikely to receive an action letter for its New Drug Application for Zohydro ER by the Prescription Drug User Fee Act, or PDUFA, goal date of March 1. Under the performance goals set by the FDA under PDUFA, the agency can miss the prescribed goal date for approximately ten percent of the NDAs that are submitted each year and still meet the performance goals for review of priority and standard applications. The FDA has not provided Zogenix with information as to the reason for the possible delay, but has indicated that the delay would likely be brief and may last only several weeks. Zogenix has not been informed of any deficiencies in the application during the review process to date. | |
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News For ZGNX From The Last 14 Days Check below for free stories on ZGNX the last two weeks. |
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| May 9, 2013 | | 16:09 EDT |  | ZGNX | Zogenix reports Q1 non-GAAP EPS (17c), consensus (14c)
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