J&J unit 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.
