In one of the largest health-care fraud settlements in US history, J&J's criminal and civil fine covers allegations the company promoted Risperdal and other prescription drugs for uses not approved as safe and effective by the Food and Drug Administration (FDA), the department said.
The settlement further covers kickbacks J&J allegedly paid to physicians and pharmacies for prescribing and promoting those drugs.
"This global settlement resolves multiple investigations involving the antipsychotic drugs Risperdal and Invega -- as well as the heart drug Natrecor and other Johnson & Johnson products," Attorney General Eric Holder said in a statement.
J&J is to pay USD 485 million in criminal fines and forfeiture and a total of USD 1.72 billion in civil settlements with the federal government and states.
The government charged that J&J unit Janssen Pharmaceuticals had promoted Risperdal without FDA approval for treatment of psychotic symptoms and associated behavioral disturbances exhibited by elderly, non-schizophrenic dementia patients.
Janssen will pay a total of UDS 400 million, including a criminal fine of USD 334 million and forfeiture of USD 66 million. Janssen's guilty plea requires approval by the US district court.
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