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FDA approves AstraZeneca's Seroquel

14 May 2008

AstraZeneca has announced that Seroquel has been approved by the US Food and Drug Administration (FDA) for the treatment of bipolar I disorder.

The approval is based on two clinical studies which evaluated the effectiveness of the drug as a maintenance treatment for adult patients with the disorder.

Bipolar disorder affects about eight million adults in the US and patients often experience recurring manic episodes and depression.

"We believe Seroquel's a very viable treatment option for treating people with mental illnesses," AstraZeneca spokesman Jim Minnick recently told delawareonline.com.

The drug is currently used to treat schizophrenia and is AstraZeneca's second best-selling drug, totalling more than $4 billion (£2 billion) in sales in 2007.

It is estimated that Seroquel has been prescribed to more than 22 million patients worldwide and the company is now seeking approval for it to be used as a bipolar I disorder treatment in Europe.

The drug was first launched in 1997.

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