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J&J reaches some agreement on U.S. Risperdal probe
August 10, 2011 / 12:30 PM / 6 years ago

J&J reaches some agreement on U.S. Risperdal probe

NEW YORK, Aug 10 (Reuters) - Johnson & Johnson (JNJ.N) said it reached an agreement related to a misdemeanor charge stemming from a federal investigation into the marketing of its Risperdal schizophrenia treatment, although some issues remain unresolved.

In its quarterly securities filing, J&J said that discussions have been ongoing to resolve criminal penalties related to the promotion of Risperdal, a onetime big-selling product for the company.

“An agreement in principal on key issues relevant to a disposition of criminal charges pursuant to a single misdemeanor violation of the Food Drug and Cosmetic Act has been reached, but certain issues remain open before a settlement can be finalized,” J&J said in the filing.

J&J said it had adjusted the amount accrued in the second quarter to cover the financial component of the proposed criminal settlement.

The U.S. government also plans to intervene in whistle-blower suits alleging “off-label” promotion of Risperdal and file a superseding complaint, J&J said in the filing. Off-label promotion refers to marketing of a drug outside of its approved uses. (Reporting by Lewis Krauskopf, editing by Gerald E. McCormick)

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