AstraZeneca files Seroquel for MDD with MHRA
Anglo-Swedish drug major AstraZeneca has submitted an application to the Medicines and Healthcare products Regulatory Agency (MHRA) seeking a new license for Seroquel (quetiapine fumarate) as a treatment for major depressive episodes associated with bipolar disorder. At present, the drug has UK approval for the treatment of schizophrenia and manic episodes associated with bipolar disorder (Marketletters passim).
AstraZeneca said that the submission dossier contains data from the BOLDER I and II studies (Marketletter September 3, 2007) which indicate the product's efficacy and tolerability when used as a monotherapeutic treatment for MDD associated with bipolar disorder.
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