RoxyBond Gets US Advisory Panel OK For Abuse-Deterrent Claim Despite Excipient Concerns
Members unanimously endorse product and mostly supported abuse-deterrent language; several panelists suggest warning about possible harmful effects of excipients by abusing product intravenously.
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US FDA Proactively Exploring Hydexor Abuse Potential Ahead Of Ad Comm For Anti-Emetic/Opioid Combo
Charleston Labs is not seeking abuse-deterrent labeling for Hydexor, but FDA has been monitoring online web forums to spot patterns of abuse of the active ingredients to determine if inclusion of promethazine translates to greater risk of abuse than for other hydrocodone products.
RoxyBond Clears US FDA With Abuse-Deterrent Properties, But No REMS Yet
Inspirion's oxycodone is first immediate-release opioid approved with abuse-deterrent language in labeling.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.