Advisory Committees Turn Down Opana IR Pediatric Labeling
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.