ARTICLE | Clinical News

FDA tentatively approves abuse deterrent claim for Egalet's Arymo ER

December 22, 2017 6:39 PM UTC

Egalet Corp. (NASDAQ:EGLT) said FDA granted tentative approval to an expanded label for Arymo ER morphine sulfate extended-release tablets to include data from a Category 2/3 intranasal human abuse potential study and an intranasal abuse deterrent claim. The product is approved 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. Egalet said final approval is expected when the exclusivity FDA granted another company expires on Oct. 2, 2018...

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