Irish Pharmaceutical Company and U.S. Subsidiary to Pay $203M for Off-Label Marketing

An Irish pharmaceutical company and its U.S. subsidiary have agreed to pay the federal government more than $203 million after pleading guilty to illegal promotion of its epilepsy drug Zonegran, according to a Washington Post news report.

Although the Food and Drug Administration only approved Zonegran for treatment of epilepsy, Elan admitted to illegally promoting the drug for off-label uses not approved by the FDA, including mood stabilization, migraine headaches, eating disorders and weight loss.

As part of the settlement, Elan will pay $97 million in criminal fines and $102.3 million to resolve civil allegations. The company will also give up $3.6 million in assets. Japanese drug marketer Eisai, which bought Zongran from Elan, will also pay $11 million to the federal government for the off-label marketing.

Read the Washington Post news report about Elan's settlement.

Read other coverage about pharmaceutical fraud:

- 20 Largest False Claims Cases of 2010

- Kos Pharmaceuticals Will Pay $41M to Settle Kickback, Off-Label Promotion Allegations

- Three Pharmaceutical Companies Will Pay Combined $421M to Settle Drug-Pricing Lawsuit

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