The FDA approved AstraZeneca’s Seroquel XR (quetiapine) as an add-on treatment to antidepressants in adults with major depressive disorder (MDD). However, the agency also issued a complete response letter requesting additional information around the regulatory filings for the atypical antipsychotic as a monotherapy.

AstraZeneca is seeking approval of Seroquel XR as acute and maintenance monotherapy for the treatment of MDD. The company said that it is evaluating the contents of the complete response letter and will continue discussions with the US regulator.

Earlier in the year, an FDA advisory panel unanimously voted that the drug was not safe enough for use as monotherapy in treating MDD, concluding that Seroquel XR offered no clear advantage over older drugs.

In approving Seroquel XR as an add-on therapy, the US regulator requested that AstraZeneca implement a risk evaluation strategy.

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Reference Articles

US FDA approves Seroquel XR for add-on treatment of major depressive disorder - (AstraZeneca)

US FDA approves Seroquel for the pediatric treatment of schizophrenia and bipolar mania - (AstraZeneca)

AstraZeneca: FDA clears Seroquel XR as add-on for MDD - (Easybourse)

AstraZeneca gets FDA OK for Seroquel XR add-on - (MarketWatch)

AstraZeneca advances on partial US drug approval - (The Guardian)

FDA approves Seroquel XR for limited use in depression - (The Wall Street Journal)

AstraZeneca drug wins partial US approval - (Yahoo!Finance)