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Seroquel Gains FDA Approvals for Add-on Depression Treatment, Pediatric Schizophrenia

The U.S. Food and Drug Administration (FDA) announced this past week that two types of Seroquel-brand (quetiapine fumarate) atypical antipsychotic medications have been approved for two different mental health treatments — for use as an add-on treatment for depression, and for pediatric schizophrenia and bipolar mania.

The FDA approved once-daily Seroquel XR (quetiapine fumarate) Extended Release Tablets as adjunctive (add-on) treatment to antidepressants in adults with Major Depressive Disorder on Friday. Seroquel XR is reportedly the only medication in its class approved by the FDA to treat both major depressive disorder as adjunctive therapy and acute depressive episodes associated with bipolar disorder as monotherapy, the AstraZeneca, the drug’s manufacturer, said.

This approval for Seroquel XR provides physicians and psychiatrists with a new add-on treatment option for people with depression who may not be responding to their current antidepressant.

The company also announced on Friday that Seroquel (quetiapine fumarate) tablets were approved by the FDA for the treatment of schizophrenia in adolescents (13-17 years of age) as monotherapy (single-drug therapy). The FDA also announced approval of the same drug for the acute treatment of manic episodes associated with bipolar I disorder in children and adolescents (10-17 years of age), both as monotherapy and as an adjunct to lithium or divalproex.

“Bipolar mania and schizophrenia in children and adolescents, while rare, are serious disorders and it is important to have treatments approved for use in this patient population,” said Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca.

“Because individuals respond differently to medications,” he noted. “Patients and practitioners need proven treatment options that permit them to weigh safety and efficacy in individual circumstances. These new indications for Seroquel provide another FDA-approved option for treating pediatric patients suffering from these severe mental illnesses.”

The Seroquel pediatric approval is based on data from four studies, the company said. Three of the studies (Study 112, Study 149, and Study 150) evaluated the efficacy and safety of Seroquel in the treatment of adolescents with schizophrenia (13-17 years of age) or children and adolescents with bipolar I disorder (10-17 years of age).

The fourth study (Study 28) assessed the pharmacokinetic profile of Seroquel in children and adolescents. Doses of 400 mg to 800 mg of Seroquel were specifically studied in the pediatric program.

Seroquel is part of a class of drugs called atypical antipsychotics and is approved for a number of mental health disorders. In addition to today’s approval for the adjunctive treatment of MDD, The Seroquel XR formulation is currently approved for the acute and maintenance treatment of bipolar disorder and schizophrenia.

Source: AstraZeneca news releases

Seroquel Gains FDA Approvals for Add-on Depression Treatment, Pediatric Schizophrenia

Psych Central News Editor

APA Reference
News Editor, P. (2018). Seroquel Gains FDA Approvals for Add-on Depression Treatment, Pediatric Schizophrenia. Psych Central. Retrieved on April 19, 2019, from
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Last updated: 8 Aug 2018
Last reviewed: By a member of our scientific advisory board on 8 Aug 2018
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