AstraZeneca Receives FDA Approval For Seroquel XR

The FDA has approved once-daily AstraZeneca’s Seroquel XR (quetiapine fumarate) extended release tablets as adjunctive treatment to antidepressants in adults with major depressive disorder (MDD).

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

AstraZeneca is evaluating the contents of the CRL. AstraZeneca will continue discussions with the FDA and will provide a response to the agency 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 has required that AstraZeneca implement a Risk Evaluation and Mitigation Strategy (REMS). The REMS for Seroquel XR requires a Medication Guide and periodic assessments that will include a survey of patients’ understanding of the potential risks of Seroquel XR. The REMS applies to all approved indications.

Lisa Schoenberg, VP of specialty care at AstraZeneca, said: “Today’s FDA approval of Seroquel XR is based on a clinical development program in MDD involving 939 patients randomized across two studies that assessed the efficacy and safety of once-daily treatment with Seroquel XR as adjunctive treatment to antidepressants. This new indication for Seroquel XR marks an important milestone in the treatment of MDD, as there is a significant need for additional options that may help patients with this devastating condition who are not adequately responding to their antidepressant therapy.”