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FDA approves Seroquel XR for MDD

The FDA has approved Seroquel XR as an adjunctive treatment to antidepressants in adults with Major Depressive Disorder

AstraZeneca (AZ) today announced that the US Food and Drug Administration (FDA) has approved once-daily Seroquel XR (quetiapine fumarate) extended release tablets as an adjunctive treatment to antidepressants in adults with Major Depressive Disorder (MDD).

Manufactured by AZ, Seroquel XR is the only medication in its class approved by the FDA to treat both MDD as an adjunctive therapy, and acute depressive episodes associated with bipolar disorder as monotherapy. 

Traditionally MDD has been treated with antidepressants, with selective serotonin reuptake inhibitors (SSRIs) among the most commonly prescribed class. In many cases, however, patients fail to respond adequately to treatment. The approval for Seroquel  XR provides physicians with a new adjunctive treatment option for patients with MDD who have an inadequate response to their current antidepressant. 

In addition to this approval of Seroquel XR for the adjunctive indication in MDD, AZ has received a Complete Response Letter (CRL) from the FDA asking for additional information for the Supplemental New Drug Application (SNDA) for Seroquel XR as acute monotherapy and maintenance monotherapy for the treatment of MDD in adult patients. 

AZ is evaluating the contents of the CRL and will provide a response to the FDA in due course. The CRL does not change the current recommendations for the treatment of patients taking Seroquel XR for approved indications in schizophrenia and bipolar disorder. 

The FDA also requires that AZ implement a Risk Evaluation and Mitigation Strategy (REMS) for Seroquel XR, consisting of a medication guide and periodic assessments that will include a survey of patients' understanding of the potential risks of the drug. The REMS applies to all approved indications.

7th December 2009

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