FDA Approves Bipolar Drug From AstraZeneca
October 10th, 2008 | by admin |
The Food and Drug Administration (FDA) have approved Seroquel XR tablets manufactured by AstraZeneca to treat patients diagnosed with bipolar disorder.
According to the company, the approval of their drug marks the first such approval by the FDA of a drug to treat the depressive symptoms associated with bipolar disorder.
The FDA approved the drug based on clinical trials pitting Seroquel XR tablets against a placebo in a randomized trial of more than 300 patients with bipolar disorder.
The company stated that it had earlier submitted 2 independent applications to the FDA for approval of the drug based on its ability to treat both depressive and manic symptoms associated with bipolar disorder.
“These new indications for SEROQUEL XR mark an important milestone in the treatment of bipolar disorder,” said Lisa Schoenberg, VP Specialty Care, AstraZeneca.
The mental health condition is very serious, and is characterized by continuing bouts of manic depression and mood swings.
