Revamped Pfizer Drug Becomes Third FDA-Approved Abuse-Deterrent Opioid

October 17, 2014 at 6:29 PM
FDA Friday (Oct. 17) approved labeling for a third abuse-deterrent, extended-release opioid consistent with guidance on abuse-deterrent opioids evaluation and labeling. Pfizer's Embeda, first approved in 2009, will now have labeling with information about the product's oral and nasal abuse-deterrent properties, FDA said. Embeda, a morphine sulfate and naltrexone hydrochloride tablet, releases only morphine when taken properly. When crushed, the naltrexone blocks some of the euphoric effects of the morphine and can cause withdrawal in people dependent on or tolerant...


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