Drugs and Devices

FDA approves new labeling for Embeda ER capsules

On Oct. 17, the U.S. Food and Drug Administration (FDA) approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an 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. Embeda is the third ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance, “Abuse-Deterrent Opioids – Evaluation and Labeling”. Read more.


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