Opana IR Pediatric Labeling Supplement Faces US FDA Panel Review
Endo seeks to add findings from two open-label pediatric studies to labeling for its immediate-release opioid analgesic but is not seeking a pediatric use indication; advisory committee also will consider whether something more than routine pediatric safety monitoring is needed for Purdue’s OxyContin, which added a pediatric indication in 2015.
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Endo’s Opana IR Should Not Add Pediatric Data To Labeling, US FDA Panel Says
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.
Pediatric Opioid Development Faces Grim Outlook After Advisory Cmte.
Panelists appeared to have more questions than answers as the common cliché of 'more research is needed' dominated the two-day meeting.