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April 9, 2014
05:16 EDTZGNXZogenix requested order staying the ban of Zohydro in MA
Today Zogenix presented its case in U.S. District Court in Boston requesting an immediate order staying the ban on the FDA-approved prescription drug product, Zohydro ER extended-release capsules, entered on March 27, by Massachusetts Governor Deval Patrick. A follow-up hearing has been scheduled for Monday, April 14. The company will continue to monitor, evaluate and take appropriate actions in all states specific to Zohydro ER to ensure that all FDA-approved Schedule II prescription opioids covered by the FDA mandated Risk Evaluation Mitigation Strategy for extended-release and long-acting opioid analgesics receive equal treatment for any rules that impact patient access and prescribing.
News For ZGNX From The Last 14 Days
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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analgesic with FDA-approved labeling describing the productís abuse-deterrent properties consistent with the FDAís 2013 draft guidance for industry, the FDA stated.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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