A subsidiary of Johnson & Johnson entered a plea of guilty on Wednesday to charges of misbranding a heart failure drug, according to a U.S. Department of Justice announcement.
Scios Inc. of California admitted to misbranding the drug Natrecor and will pay an $85 million fine for the misdemeanor violation of the Food, Drug and Cosmetic Act.
The drug was approved by the Food and Drug Administration strictly for intravenous treatment of patients suffering from "acutely decompensated congestive heart failure" (CHF). However, the company branded the drug as intended for non-acute CHF patients to be administered on a scheduled basis, a use for which Natrecor was not approved by the FDA.
According the the DOJ announcement, if a drug company introduces a drug into interstate commerce for an unapproved use, the drug is considered misbranded.
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