Fremont, Calif.-based Scios, a subsidiary of Johnson & Johnson, has pleaded guilty to misbranding its heart failure drug Natrecor and will pay an $85 million criminal fine, according to a news release from the Department of Justice.
Scios admitted that it intended the drug be used for purposes not approved by the FDA. The company admitted that the FDA-approved labeling for the drug did not contain any directions for scheduled, serial use to treat chronic, non-acute congestive heart failure patients — which is how Scios intended the drug be used.
Read more at Becker’s ASC Review.