Violation Tracker Individual Record
Aegerion Pharmaceuticals Inc., a Cambridge, Massachusetts-based subsidiary of Novelion Therapeutics Inc., agreed to plead guilty to charges that that its prescription drug Juxtapid was misbranded because, among other things, Aegerion failed to comply with a Risk Evaluation and Mitigation Strategy (REMS). The resolution also included a deferred prosecution agreement relating to criminal liability under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). In addition, Aegerion agreed to settle allegations that it caused false claims to be submitted to federal health care programs for Juxtapid.? Aegerion agreed to pay more than $35 million to resolve criminal and civil liability arising from these matters.