A new formulation of extended-release quetiapine, an atypical antipsychotic medication, should not be approved as a monotherapy for major depressive disorder and generalized anxiety disorder because of serious cardiac and metabolic adverse events associated with use of the drug, according to an advisory panel to the US Food and Drug Administration (FDA). The panel, however, voted in favor of approving more limited use of quetiapine as an adjunctive therapy in treatment-refractory depression.
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Federal authorities are considering approval of a new formulation of quetiapine for treating depression. A different formulation of the drug is currently approved as a treatment for schizophrenia and bipolar disorder.
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