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News Breaks
November 8, 2012
09:37 EDTZGNXZogenix announces FDA Advisory Committee to review Zohydro ER NDA on Dec. 7
Zogenix announced that the U.S. FDA Anesthetic and Analgesic Drug Products Advisory Committee, or AADPAC, will review the company's New Drug Application, or NDA, for Zohydro ER -- hydrocodone bitartrate extended-release capsules -- on Dec. 7, 2012. Zohydro ER is Zogenix's lead investigational product candidate 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. Details of the meeting agenda will be available in the Federal Register. The Prescription Drug User Fee Act, or PDUFA, date for completion of the review by the FDA is March 1, 2013. If approved, Zohydro ER will be classified as a Drug Enforcement Agency, or DEA, Schedule II drug, subject to stricter prescribing and dispensing rules compared to the currently prescribed hydrocodone products.
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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 Hysingla ER has approved labeling describing the productís abuse-deterrent properties consistent with the FDAís 2013 draft guidance for industry.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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