AstraZeneca Submits Seroquel sNDA

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By: Tim Wright

Editor-in-Chief, Contract Pharma

AstraZeneca has submitted an sNDA to the FDA for a new indication for Seroquel for the treatment of patients with depressive episodes associated with bipolar disorder. Seroquel is currently approved for the treatment of acute manic episodes associated with bipolar I disorder and the treatment of schizophrenia. The sNDA submission is based on results from the BOLDER I and BOLDER II (BipOLar DEpRession) trial programs. Both studies were double-blind, placebo-controlled trials of outpatients w...

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