DC Circ. Upholds FDA's Abuse-Deterrent Opioid Denial

Law360 (May 1, 2020, 5:48 PM EDT) -- The D.C. Circuit on Friday upheld the U.S. Food and Drug Administration's denial of Pharmaceutical Manufacturing Research Services Inc.'s application for an abuse-deterrent form of oxycodone because there was no evidence a dye in the drug could deter abuse.

The panel rejected PMRS' argument that a false or misleading label isn't a sufficient statutory ground for denying a new drug application. The company had contended that the Food Drug and Cosmetic Act doesn't allow the FDA to reject an application on the sole basis of a false or misleading label.

Specifically, the company had pointed to a section of the FDCA...

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