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Forest Pharmaceuticals Agrees to Guilty Plea for Violating FDA Laws
Date:9/15/2010

etter to stop the manufacture and distribution of Levothroid.

"These charges should serve as a warning to industry that the FDA takes seriously its role to protect the public from unapproved drugs," said Deborah M. Autor, director of the Office of Compliance in FDA's Center for Drug Evaluation and Research. "Any company that operates in violation of the FDCA and ignores FDA's warnings should be aware that a criminal action could follow."

Forest Pharmaceuticals, Inc. also is charged with distribution of a misbranded drug for its off-label promotion of Celexa for pediatric use when it was approved only for use in adults. Celexa is the brand name for the prescription drug citalopram, a selective serotonin reuptake inhibitor (SSRI) drug for the treatment of adult depression. In addition, Forest Pharmaceuticals, Inc. also is charged with obstructing an agency proceeding because of false statements made by its employees during a 2003 FDA inspection.

Under the terms of the plea agreement, Forest Pharmaceuticals, Inc. will plead guilty to all three counts brought against the company and will pay criminal penalties totaling $164 million. The Department of Justice also announced that Forest Pharmaceuticals, Inc. and its parent company, Forest Laboratories, Inc., have agreed to pay $149 million and to enter into a Corporate Integrity Agreement with the Office of Inspector General of the U.S. Department of Health and Human Services in order to resolve a related civil complaint against the companies.

Consumers should be aware that the Levothroid product currently marketed by Forest Pharmaceuticals, Inc. is not the subject of today's actions. Forest Pharmaceutical's guilty plea and criminal penalties relate to the marketing of the previously unapproved Levothroid product.  The current Levothroid product now has an approved New Drug Application and is compliant with FDA regulations.

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SOURCE U.S. Food and Drug Administration
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