FDA's Opioid Regret? Skipping Another Zohydro Meeting, Califf Says
This article was originally published in The Pink Sheet Daily
Agency addressed post-marketing concerns raised by advisory committee, Commissioner tells Senate, but should have returned to get panel's blessing.
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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.
Advisory committees will discuss whether data from a 41-patient study should be added to Pediatric Use section of labeling for Purdue's buprenorphine product; agency's decision to convene expert panel even though a pediatric indication is not being considered grew out of criticism generated by approval of OxyContin for adolescents.
FDA’s Anesthetic and Analgesic Drug Products Advisory Committee wants Risk Evaluation and Mitigation Strategies enhanced for all extended-release/long-acting opioids as it recommends 11-2, one abstention, against approval of Zogenix’s single-entity hydrocodone product.