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Stock Market & Financial Investment News

News Breaks
July 9, 2014
08:33 EDTZGNXZogenix reports positive development on U.S. District Court ruling
Zogenix commented on the order issued by the U.S. District Court in Massachusetts upholding its prior decision that imposing regulations to restrict access to Zohydro ER Extended-Release Capsules, CII, violates Constitutional law. The court's decision supports the importance of upholding the principle at the heart of this case, which is that the FDA is the only regulatory body that is authorized to determine the approval and access of medicines for all Americans. On October 25, 2013, the FDA approved Zohydro ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, and today's decision preserves access for those in Massachusetts who may benefit from its medical attributes and sets a precedent for other states seeking to unjustly restrict access to Zohydro ER. Zogenix will continue to work to ensure patients have access to Zohydro ER in every state in a manner that is consistent with all extended-release opioids.
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November 20, 2014
14:26 EDTZGNXZogenix slips after FDA approves new extended-release opioid analgesic
Shares of Zogenix, the maker of Zohydro ER, are lower in afternoon trading after the FDA approved Hysingla ER, another extended-release opioid analgesic. WHAT'S NEW: Earlier, the Food and Drug Administration announced it has approved Hysingla ER, which is an extended-release 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. Hysingla ER has approved labeling describing the productís abuse-deterrent properties consistent with the FDAís 2013 draft guidance for industry. Hysingla ER is manufactured by Purdue Pharma. WHAT'S NOTABLE: Janet Woodcock, the director of the Center for Drug Evaluation and Research, stated in a post to the "FDA Voice" blog, that the approval of Hysingla ER marks additional progress in the fight against the ongoing misuse and abuse of prescription opioids. In her blog post, Woodcock stated: "While Hysingla ER has the same active ingredient, hydrocodone, as Zohydro ER, the only other approved extended-release hydrocodone product, there are important differences between the two." Hysingla ER has approved abuse-deterrent labeling, while Zohydro ER does not, Woodcock noted. The CDER director also stated that the FDA has not yet determined whether Hysingla ER will prove to be safer than Zohydro ER. PRICE ACTION: In afternoon trading, shares of Zogenix slipped 1.7% to $1.18.

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