FDA nod for Seroquel XR in bipolar disorder
Anglo-Swedish drug major AstraZeneca has received an additional US Food and Drug Administration approval for Seroquel XR (quetiapine fumarate) extended-release tablets for the treatment of both depressive and manic episodes associated with bipolar disorder.
The therapy is now cleared by the FDA for the once-daily acute treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar I disorder, and for maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex.
Seroquel XR is the slow-release version of AstraZeneca's Seroquel, the patent for which expires in 2011. The firm is hoping the former, already approved for the treatment of schizophrenia, will replace the $4.03 billion in sales that the original Seroquel brought in last year.
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