Health Law & Business News

FDA’s Rejection of ‘Abuse Deterrent’ Version of Oxycodone Upheld

May 1, 2020, 4:24 PM

The FDA properly denied Pharmaceutical Manufacturing Research Services Inc.'s application for a new version of oxycodone with “abuse deterrent” properties because of its proposed label, a federal appeals court in Washington said Friday.

The agency said the drugmaker’s proposed label was false and misleading because no evidence had been provided showing the drug actually had properties that made it less likely to be abused than other opioids, the U.S. Court of Appeals for the District of Columbia Circuit said.

PRMS submitted a new drug application to the Food and Drug Administration in 2017 for an immediate release formulation of oxycodone....

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