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Zogenix Inc Receives FDA Approval for Zohydro ER (Hydrocodone Bitartrate) Extended-Release Capsules


Friday, 25 Oct 2013 05:01pm EDT 

Zogenix Inc announced that the U.S. Food and Drug Administration (FDA) has approved Zohydro ER (hydrocodone bitartrate) extended-release capsules, an opioid agonist, extended-release oral formulation of hydrocodone without acetaminophen, 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. Zogenix expects to launch Zohydro ER in approximately four months. Zohydro ER is the first extended-release formulation hydrocodone therapy without acetaminophen. The use of products containing acetaminophen in high doses over long periods of time has the potential for causing liver injury. Acetaminophen overdose is a cause of acute liver failure in the United States, with 63% of unintentional acetaminophen overdoses attributed to the use of hydrocodone-acetaminophen combination products. 

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