February 13, 2019
Otsuka Pharmaceutical Co., Ltd.
Avanir Pharmaceuticals, Inc. Reaches Agreement in Principle with U.S. Department of Justice
Regarding NUEDEXTA (dextromethorphan HBr and quinidine sulfate) 20 mg/10 mg capsule
Avanir Pharmaceuticals, Inc., an indirect, California-based subsidiary of Otsuka Pharmaceutical Co., Ltd., has reached an agreement in principle to resolve the United States (U.S.) Department of Justice's investigation related to certain of Avanir's sales and marketing practices for its product NUEDEXTA® (dextromethorphan HBr and quinidine sulfate) 20 mg/10 mg capsules prior to 2017. The agreement in principle between Avanir and the U.S. is contingent upon the parties' negotiation and execution of civil, criminal and administrative agreements.
The impact on our parent company Otsuka Holdings' 2018 financial results will be included in its fourth quarter earnings announcement and other relevant materials issued today.
Until the agreements with the government are finalized, Otsuka will not be able to provide additional details. Avanir will provide more information regarding this matter once those agreements are executed.
Information in this news release was current as of the original release date.