Mallinckrodt's Abuse Deterrent Oxycodone IR Narrowly Wins US FDA Panel Backing
"Incremental" step forward is sufficient for product to be labeled as deterring abuse by nasal, but not intravenous route, advisory committee members conclude.
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Nektar's novel opioid oxycodegol will be the first opioid analgesic taken up by an advisory committee in more than a year after the agency spent 2019 reevaluating its regulatory paradigm.
Where Is OxyContin Abuse Deterrent Data? Purdue Has Sent Two Studies, But Wait Continues
US FDA expects to receive two more postmarket studies this year, but Purdue has not yet decided if it will resubmit a supplemental NDA. Consortium of 13 companies have completed six additional studies on extended-release opioids.
Opioid Sponsors Enter 2019 At A Crossroads
Recent regulatory trends at US FDA offer no clear path to success for sponsors developing opioids. As 2018 concludes with only one approval and at least five rejections, firms will need new strategies if they hope to bring the