FDA: Janssen Pharmaceuticals, Inc. to plead guilty and pay over $1.6 billion to resolve allegations of misbranding and filing false claims for its schizophrenia drug Risperdal
On behalf of the U.S. Food and Drug Administration, the U.S. Department of Justice today announced a guilty plea agreement with Janssen Pharmaceuticals, Inc., (JPI) of Titusville, N.J., and a $400 million criminal fine for introducing a misbranded drug, Risperdal (risperidone), into interstate commerce. A Johnson & Johnson Company, JPI must also pay $1.25 billion under a separate civil settlement concerning the same drug. The combined criminal plea and civil settlement agreement related to Risperdal totals $1,673,024 billion.
