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ARTICLE | Clinical News

Arymo ER morphine sulfate extended-release regulatory update

October 24, 2016 7:00 AM UTC

Egalet said it received notice from FDA that the agency would not meet the Oct. 14 PDUFA date for pain candidate Arymo ER morphine sulfate extended-release tablets, an abuse-deterrent morphine formulation. The company said FDA needed more time to review the NDA and noted the agency confirmed that the biotech did not need to submit scientific information or data. Egalet said the agency did not provide an updated time frame for a decision...