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© Reuters.
DUBLIN – Endo International plc (OTC: OTC:) has reached an settlement to settle U.S. Department of Justice (DOJ) investigations into the advertising of its opioid painkiller Opana ER by its subsidiary, Endo Health Solutions Inc. (EHSI), the corporate introduced in the present day.
The settlement features a responsible plea to a misdemeanor cost associated to advertising practices from April 2012 to May 2013 and resolves civil claims with out an admission of legal responsibility.
The funds related with the DOJ resolutions will align with the phrases of a world settlement-in-principle outlined in Endo’s proposed Plan of Reorganization, which was initially filed on December 19, 2023. The Plan is a part of the corporate’s ongoing monetary restructuring efforts.
EHSI’s responsible plea pertains to a single strict legal responsibility misdemeanor for misbranding underneath the Federal Food, Drug, and Cosmetic Act.
Despite the plea, the civil settlement doesn’t embrace any admission of legal responsibility or wrongdoing by EHSI. Endo has emphasised its cooperation with the DOJ investigations and has taken steps to boost its U.S. compliance program since 2013.
The firm has undergone important adjustments to its insurance policies, coaching, and threat administration procedures. Additionally, as a part of its restructuring course of, Endo agreed to a Voluntary Operating Injunction in November 2022, which can stay efficient till August 2030.
Endo’s proposed Plan of Reorganization, inclusive of the DOJ settlement, is pending approval from the Bankruptcy Court. A listening to to substantiate the Plan is scheduled for March 19, 2024. The firm has said that the DOJ resolutions don’t impose new compliance obligations on entities that will buy the corporate’s property post-restructuring.
This announcement relies on a press launch assertion from Endo International plc.
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