FDA Stalls On Collegium's 'Abuse-Deterrent' Painkiller
Law360, New York (October 13, 2015, 6:24 PM EDT) -- The U.S. Food and Drug Administration didn't finish its review — which had been expected on Monday — of Collegium Pharmaceutical Inc.'s purported abuse-deterrent opioid painkiller that an FDA panel supported at a meeting last month, according to a statement on Monday by the drugmaker that didn't indicate a reason for the delay.
Collegium said in the statement that the agency had told it that it hadn't finished reviewing the drugmaker's new drug application for the opioid painkiller Xtampza, which would come in the form of an extended-release capsule mean to treat severe pain that needs "daily, around-the-clock, long-term opioid treatment,"...
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