U.S. health authorities agency (FDA) have approved AstraZeneca´s once-daily Seroquel XR (generically quetiapine) – extended release tablets - for the acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex.

The company noted that Seroquel XR is the first medication approved by the FDA for the once-daily acute treatment of both depressive and manic episodes associated with bipolar disorder. It has also been approved as a long-term treatment option for bipolar I disorder.

The drug generated over $ 2.16 billion dollars in 1H2008 for AstraZeneca, competing with Johnson & Johnson´s Risperdal family of anti-psychotic drugs, which made over $ 2.17 billion in the same period. The patent of the older version of Seroquel expires in 2011, while the extended release patent expires in 2017.

Approval of the extended release version was based on two different studies: for the bipolar disorder, tests included 280 patients, while the data for the manic bipolar episodes´ approval was based on a study among 316 patients.