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.

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