AstraZeneca gets FDA approval for one new Seroquel use

WASHINGTON The Food and Drug Administration has approved AstraZeneca’s bipolar and schizophrenia drug Seroquel as an adjunct to lithium or divalproex, manufactured by Abbott Laboratories, for the maintenance treatment of patients with bipolar I disorder. This is one of five approvals for new indications that the company is looking for the drug.

Earlier this month, AstraZeneca submitted an application for Seroquel XR tablets to treat generalized anxiety disorder, including maintenance of the anti-anxiety effect.

In January, the company filed two separate applications to the FDA for Seroquel XR to treat manic and depressive episodes associated with bipolar disorder. The following month, it filed an application seeking approval for the treatment of major depressive disorder with the drug as monotherapy, adjunct therapy and maintenance therapy. The FDA is reviewing those submissions.

Global sales of Seroquel in 2007 were $4.02 billion, the company said.