Bryan Cohen Feb. 8, 2013, 7:40pm

FRANKFORT, Ky. (Legal Newsline) - Kentucky Attorney General Jack Conway announced a $5.5 million settlement Thursday with AstraZeneca Pharmaceuticals LP to resolve allegations of off-label marketing of Seroquel, its atypical antipsychotic drug.

The settlement resolves allegations that AstraZeneca illegally marketed Seroquel for uses not approved as being effective and safe by the U.S. Food and Drug Administration. The company allegedly promoted the drug for off-label uses in children and the elderly well before establishing the drug was not effective or safe for any use by patients of those ages.

The FDA only approved Seroquel for the treatment of schizophrenia and various bipolar disorders in adults.

"I am pleased that we have reached this settlement and are recovering millions of dollars for a vital state program and for taxpayers," Conway said. "We've sent a clear message today that Kentucky will not tolerate drug companies that put profits ahead of patient care."

Under the terms of the settlement, AstraZeneca will pay the Kentucky Medicaid program more than $3.3 million. The other $2.2 million will be distributed on a pro-rata basis to the Kentucky Department for Behavioral Health, Development and Intellectual Disabilities, the Kentucky Department of Corrections, the Department for Juvenile Justice, the University of Louisville Hospital and the University of Kentucky Medical Center. The pro-rata distribution is the result of off-label utilization at the respective agencies.

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