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AstraZeneca Submits sNDA for SEROQUEL XR(TM) for the Treatment of Major Depressive Disorder
Date:2/29/2008

ce (18%-28% vs 7%-8%), dizziness (11%-18% vs 5%-7%), constipation (8%-10% vs 3%-4%), SGPT increase (5% vs 1%), dyspepsia (5%-7% vs 1%-4%), lethargy (5% vs 2%), and weight gain (5% vs 1%). The most commonly observed adverse events associated with the use of SEROQUEL versus placebo in clinical trials as adjunct therapy with lithium or divalproex in bipolar mania were somnolence (34% vs 9%), dry mouth (19% vs 3%), asthenia (10% vs 4%), constipation (10% vs 5%), abdominal pain (7% vs 3%), postural hypotension (7% vs 2%), pharyngitis (6% vs 3%), and weight gain (6% vs 3%). The most commonly observed adverse events associated with the use of SEROQUEL XR versus placebo in clinical trials for schizophrenia were dry mouth (12% vs 1%), constipation (6% vs 5%), dyspepsia (5% vs 2%), sedation (13% vs 7%), somnolence (12% vs 4%), dizziness (10% vs 4%), and orthostatic hypotension (7% vs 5%).

In long-term clinical trials of quetiapine, hyperglycemia (fasting glucose 126 mg/dL) was observed in 10.7% of patients receiving quetiapine (mean exposure 213 days) vs 4.6% in patients receiving placebo (mean exposure 152 days).

Please see Prescribing Information, including Boxed Warnings, for SEROQUEL (http://www1.astrazeneca-us.com/pi/seroquel.pdf) and SEROQUEL XR (http://www1.astrazeneca-us.com/pi/seroquelxr.pdf).

About Major Depressive Disorder

Major depressive disorder is a serious medical illness affecting 15 million American adults, or approximately 5 to 8 percent of the adult population in a given year. Depression occurs twice as frequently in women as in men. Unlike normal emotional experiences of sadness, loss, or passing mood states, major depressive disorder is persistent and can significantly interfere with an individual's thoughts, behavior, mood, activity, and physical health. Among all medical illn
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SOURCE AstraZeneca
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