FDA panel issues mixed decision on quetiapine in depression and anxiety.

摘要

ANEW FORMULATION OF EX-tended-release quetiapine, an atypical antipsychotic medication, should not be approved as a mono-therapy 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. Quetiapine fumarate, sold under the brand name Seroquel (AstraZeneca Pharmaceuticals, Wilmington, Del), is currently approved for the treatment of schizophrenia and acute episodes of mania and depression in patients with bipolar disorder. But the drug's maker is seeking approval for wider use of another formulation of the drug, quetiapine maleate. The FDA ultimately will decide whether to allow wider marketing of this new formulation, although the agency usually follows the advice of its advisory committees.