ALISO VIEJO, Calif., Sept. 26, 2019 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (Avanir) announced today that it has reached a resolution of civil, criminal, and administrative claims with the federal government and participating state authorities. Avanir previously disclosed in February 2019 that an agreement in principle had been reached regarding certain sales and marketing practices for its product NUEDEXTA® (dextromethorphan HBr and quinidine sulfate) 20mg/10mg capsules prior to 2017. Under the agreements, the company will pay approximately $116 million to federal and state governments.
As a part of the resolution, Avanir has entered into a False Claims Act (FCA) Agreement with various government agencies, a Deferred Prosecution Agreement (DPA) with the United States Department of Justice (DOJ) for a period of three years, and a Corporate Integrity Agreement (CIA) with the United States Department of Health and Human Services Office of Inspector General (HHS-OIG) for a period of five years. In connection with these agreements, Avanir will continue to enhance its robust compliance program.
Avanir fully cooperated with the U.S. Government throughout the investigation and engaged in extensive remedial measures. The individuals listed in the resolution agreements are no longer Avanir employees.
"The company takes its responsibilities to patients, their families and caregivers, and healthcare providers very seriously," said Avanir's President and Chief Executive Officer Wa'el Hashad. "Avanir is deeply committed to regulatory and legal compliance, integrity and ethical behavior, and the health and safety of patients. Strengthening our culture of compliance has been one of my top priorities since I joined Avanir in 2017. We will ensure that our mission, vision, and values are upheld at every level of our company every day."
Mr. Hashad added, "We are pleased to resolve this matter, move forward, and continue to develop innovative central nervous system treatments that improve the lives of patients and their care communities."
About Avanir Pharmaceuticals, Inc.
Avanir is committed to delivering innovative central nervous system (CNS) solutions to improve the lives of patients and their care communities. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing CNS treatments in areas of high unmet medical need. For more information about Avanir, please visit http://www.avanir.com.
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SOURCE Avanir Pharmaceuticals, Inc.