Scios Inc. Announces Agreement with Department of Justice Regarding NATRECOR®
Raritan, NJ (October 5, 2011) – Today Scios Inc. announced an agreement with the United States Department of Justice to resolve allegations of misbranding of NATRECOR® (nesiritide), a prescription medication for patients with heart failure.
As part of this agreement, Scios Inc. entered a guilty plea to a single misdemeanor violation of the Food, Drug and Cosmetic Act, and agreed to pay an $85 million fine.
Scios acknowledges that NATRECOR® was misbranded and used in a way not approved by the U.S. Food and Drug Administration because its labeling lacked adequate directions for that use, but denies any wrongful intent in connection with this plea.
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