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US FDA Has Soured On Abuse Deterrent Labeling Even Outside Of Opioids, Stimulant Docs Suggest

Executive Summary

Arbor Pharmaceuticals’ ADHD drug faces a challenging advisory committee after FDA questions whether even an effective abuse-deterrent stimulant formulation could produce a public health benefit. And the agency isn’t convinced that Arbor’s 505(b)(2) application for its immediate release amphetamine formulation has in fact demonstrated it would reduce abuse and misuse.

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