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Novelion unit Aegerion to admit guilt and pay $36M to settle Juxtapid case

Sep. 22, 2017 4:07 PM ETNovelion Therapeutics Inc. (NVLNF) StockNVLNFBy: Douglas W. House, SA News Editor
  • The U.S. Department of Justice announces that Novelion's (NVLN -1.3%) Aegerion Pharmaceuticals has agreed to plead guilty and pay a $36M to settle criminal and civil charges that it misbranded Juxtapid (lomitapide).
  • Specifically, the company was charged with failing to comply with a Risk Evaluation and Mitigation Strategy (REMS), a condition of approval. It failed to give healthcare providers complete and accurate information about its intended use, homozygous familial hypercholesterolemia or HoFH, and how to properly diagnose it. It was also accused of filing a misleading REMS assessment report. In addition, the company apparently promoted Juxtapid as a treatment of high cholesterol in general without sufficient directions for such use, considered misbranding.
  • Under the terms of the plea agreement, the company will plead guilty to the charges and pay a criminal fine and forfeiture of $7.2M. It will pay $28.8M to settle civil charges of misbranding, $26.1M at the federal level and $2.7M at the state level.

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