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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