The US Food and Drug Administration has given the green light to AstraZeneca’s bipolar extended release treatment Seroquel XR (quetiapine fumarate).

The drug is the first medication approved by the FDA for the once-daily acute treatment of both depressive and manic episodes associated with bipolar disorder and the approval marks the Anglo-Swedish company’s extension of the Seroquel franchise, which is already the firm’s second-best selling product.

Specifically, the FDA approval is for the treatment of the depressive episodes associated with bipolar disorder, the manic and mixed episodes associated with bipolar 1 disorder, and the maintenance treatment of bipolar 1 disorder as adjunctive therapy to lithium or divalproex.

The approval follows the FDA’s approval in May of Seroquel in its non-extended release form as a maintenance treatment for bipolar 1 disorder as an adjunct to lithium or divalproex.

In the first quarter of this year, Seroquel brought in $1.05 billion worth of sales – a 10% increase.

However, the FDA announced early last month that Seroquel was listed as one of 20 medications that were being looked at on safety grounds. The drug was included on the list for overdose due to sample pack labelling confusion.