Opioid Abuse-Deterrent Labeling Claim Decision By FDA Could Come Soon

 
• By Cathy Dombrowski

Purdue epidemiological studies indicate reformulation of OxyContin had a positive effect on abuse and misuse of the drug, but the company says continued monitoring is needed to assess whether the positive trend continues.

Drug sponsors could soon learn what data FDA considers sufficient to support a labeling claim of abuse-deterrence for an opioid drug.

The agency has received inquiries about specific products and “whether the agency believes that those products are, in fact, abuse-deterrent,”...

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