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Litigation In Brief: Elan, Novartis Resolve Federal Marketing Investigations

Executive Summary

Elan to settle DoJ Zonegran investigation: Elan announced on July 15 that it has reached an agreement in principle with the U.S. Attorney's Office in Massachusetts to pay $203.5 million to settle an investigation of its sales and marketing practices for the antiepileptic Zonegran (zonisamide). The company said it expects to plead guilty to a misdemeanor violation of the Food, Drug, and Cosmetic Act and to enter into a corporate integrity agreement with the HHS Office of Inspector General. Eisai acquired Zonegran from Elan in 2004. In 2006, the OIG served Eisai and Elan with subpoenas requesting their marketing materials for the drug (1"The Pink Sheet," Feb. 6, 2006)

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The Office of the Inspector General has served Elan and Eisai subpoenas requesting documents and materials relating to their marketing practices for the anti-epilepsy agent Zonegran (zonisamide). The Department of Justice also subpoenaed Elan seeking similar information. Eisai acquired Zonegran from Elan in 2004 ("1The Pink Sheet" April 5, 2004, In Brief). Both companies say they will cooperate with the investigation...

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