Thursday, 3 January 2008

AstraZeneca submits sNDA for Quetiapine

AstraZeneca (In a press release) said it had submitted two supplemental new drug applications to the USFDA for its drug Seroquel (quetiapine), which is currently used in the treatment of schizophrenia.The applications seek approval for the drug to be used in the treatment of manic episodes associated with bipolar disorder, as well as bipolar depression. The Wilmington, Del.-based pharmaceutical company said the submissions were based on a clinical studies that met their primary endpoint. In the studies, the effect of Seroquel was compared to a placebo in the changing of the young mania rating scale, and Montgomery Asberg depression rating scale, in patients.AstraZeneca said it would presents the results of the study at a scientific congress later in 2008

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