May 1, 2020 / 11:57 PM / a month ago

IN BRIEF: FDA's rejection of 'abuse deterrent' opioid upheld

The U.S. Food and Drug Administration acted properly when it denied Pharmaceutical Manufacturing Research Services Inc’s application to market a “abuse deterrent” version of oxycodone because its proposed label was misleading, a federal appeals court ruled Friday.

The U.S. Court of Appeals for the District of Columbia Circuit ruled the FDA reasonably concluded the drugmaker’s draft label was false and misleading because no evidence was presented that the drug in fact possessed abuse deterrent properties.

To read the full story on Westlaw Practitioner Insights, click here: bit.ly/2yZ9I0M

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