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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to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance, “Abuse-Deterrent Opioids – Evaluation and Labeling”.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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