FDA Approves Zogenix Painkiller Despite Advisory Panel’s Objections

The FDA Oct. 25 approved Zogenix’s opioid painkiller Zohydro ER in a decision that strayed from an agency advisory panel’s overwhelming recommendation against the drug’s approval due to its “high potential for abuse.” Zohydro ER (hydrocodone bitartrate extended-release capsules) is the first FDA-approved extended release hydrocodone product not to be combined with another analgesic such as acetaminophen, making it a Schedule II controlled substance.
Washington Drug Letter