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Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-Label Drug Marketing
Date:4/27/2010

company.  Once approved, the drug may not be marketed or promoted for off-label uses.  

The FDA originally approved Seroquel in September 1997 for the treatment of manifestations of psychotic disorders.  In September 2000, FDA proposed narrowing the approval for Seroquel to the short term treatment of schizophrenia only.  In January 2004, the FDA approved Seroquel for short term treatment of acute manic episodes associated with bipolar disorder (bipolar mania).  In October 2006, the FDA approved Seroquel for bipolar depression.

The United States alleges that AstraZeneca illegally marketed Seroquel for uses never approved by the FDA.  Specifically, between January 2001 through December 2006, AstraZeneca promoted Seroquel to psychiatrists and other physicians for certain uses that were not approved by the FDA as safe and effective (including aggression, Alzheimer's disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness).  These unapproved uses were not medically accepted indications for which the United States and the state Medicaid programs provided coverage for Seroquel.

According to the settlement agreement, AstraZeneca targeted its illegal marketing of the anti-psychotic Seroquel towards doctors who do not typically treat schizophrenia or bipolar disorder, such as physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons.

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SOURCE U.S. Department of Justice
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