AstraZeneca submits NDA for sustained-release formulation of Seroquel for schizophrenia

By Lisa Kerner

Charlotte, N.C., July 18 - AstraZeneca submitted a New Drug Application to the Food and Drug Administration for a sustained-release formulation of Seroquel (quetiapine fumarate), Seroquel SR, in the treatment of patients with schizophrenia.

Clinical trials in support of the FDA submission demonstrated an effective dose range of Seroquel SR of 400-800 mg/day.

Seroquel tablets in the immediate-release formulation are approved for the treatment of acute manic episodes associated with bipolar 1 disorder and the treatment of schizophrenia.

Global sales for Seroquel reached $2.8 billion in 2005.

Symptoms of the brain disorder schizophrenia include distorted perceptions of reality, hallucinations and delusions, confused thinking, and flat or blunted emotions.

AstraZeneca is a pharmaceutical company specializing in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products based in Wilmington, Del.

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