The US Food and Drug Administration is seeking advisory committee input on pediatric labeling for opioid analgesics generally, and specifically whether new pediatric information should be added to the labeling for Endo Pharmaceuticals Inc.'s Opana IR (oxymorphone immediate-release) in light of efficacy and safety concerns raised by the sponsor's data.
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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