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Endo’s Opana IR Should Not Add Pediatric Data To Labeling, US FDA Panel Says

 
• By Sue Sutter

Incorporating data from two studies that raised safety and efficacy concerns would give a false sense of security about the drug’s use in pediatric patients, the panel majority said, while dissenters said some pediatric data in labeling is better than no information at all.

FDA Advisory Committee Feature image
An AdComm voted against approval of pediatric labeling for Opana IR.

When it comes to pediatric use of Endo Pharmaceuticals Inc.’s Opana IR (oxymorphone immediate-release), no information in labeling is better than unhelpful or potentially misleading data, a US Food and Drug Administration panel said on 26 September.

Sixteen of 25 voting members of the pediatric and drug safety/risk management advisory committees voted against adding pediatric study data to labeling for Opana IR, believing that including such information...

Advisory Committee Votes

  • No new safety signals were identified for OxyContin (oxycodone hydrochloride) extended-release tablets in the current pediatric safety review. FDA recommends continuing ongoing, routine, postmarket safety monitoring,...

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