FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Advisory Committees Turn Down Opana IR Pediatric Labeling

Oct. 8, 2019
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Two FDA advisory committees voted 16-8 against recommending pediatric labeling for Endo Pharma’s Opana IR (immediate-release oxymorphone).

Some members feared that adding pediatric information to the label would falsely imply that the agency approved a pediatric indication for the drug.

The committees also voted 20-5 in favor of the FDA continuing its current post-market safety monitoring requirement for OxyContin (oxycodone hydrochloride) extended-release tablets in pediatric patients.

Despite their support, members expressed concern about the abuse potential for opioid analgesics in pediatric patients.

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