(CN) – Eli Lilly & Co. has agreed to pay $1.4 billion and plead guilty to a federal misdemeanor of promoting its antipsychotic drug Zyprexa to treat dementia though it was not approved for that.
The Justice Department said Lilly’s $515 million fine was the largest criminal fine in history. Another $800 million will go to settle civil charges – $432 million to the federal government and $362 million to states.
The agreement will settle lawsuits from the U.S. Justice Department and the U.S. Attorney in Philadelphia.
Zyprexa has brought Lilly more than $37 billion since it was approved in 1996.
It is legal for doctors to prescribe drugs for off-label uses, but it is not legal for drug companies to promote drugs for off-label uses.