AstraZeneca has received an approvable letter from the U.S. Food and Drug Administration (FDA) in response to its Supplemental New Drug Applications (sNDAs) for the use of Seroquel as both an adjunct and monotherapy for the treatment of manic episodes associated with bipolar disorder. The company is working closely with the FDA to supply information and to finalize labeling.

"Seroquel is a treatment which has benefited millions of patients worldwide who suffer from schizophrenia, and we look forward to bringing this treatment option to the 2.3 million Americans who suffer from bipolar disorder," commented Don Beamish, Commercial Brand Leader for Seroquel. "We're excited to take the next steps toward launching this important new indication in early 2004."

Seroquel recently completed the Mutual Recognition Procedure (MRP) involving 14 European countries to extend the use of Seroquel to the treatment of mania associated with bipolar disorder.

Seroquel, indicated for the treatment of schizophrenia in adults since 1997, is the fastest-growing leading atypical antipsychotic on the market. Since its initial approval, there have been approximately 18.7 million prescriptions written for Seroquel, for more than 4.7 million patients in the United States.