Endo Seeks To Block Generics Of Opana ER That Are Not Crush-Resistant
This article was originally published in The Pink Sheet Daily
Endo citizen petition asks FDA to determine that the company’s old formulation was withdrawn for safety reasons and to decline approval of ANDAs of that formulation; Purdue Pharma files third OxyContin citizen petition.
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Agency seeks long-acting opioid’s withdrawal due to evidence the reformulated version increased intravenous abuse; FDA’s action, which Endo is weighing, portends a hard-line stance when it comes to opioid risks under new Commissioner Scott Gottlieb.
FDA advisory committees will weigh concerns that Endo’s reformulated version of oxymorphone extended-release, which does not contain abuse-deterrent labeling, has shifted preferred non-oral route of abuse from intranasal to intravenous, which carries additional safety risks.
Court finds Actavis infringed two Endo patents, judge to decide whether to award damages. Actavis' non-crush-resistant generic has impeded sales of Endo's newer crush-resistant version.