FDA approves Seroquel for adolescents

6/11/2009

WILMINGTON, Del. An advisory committee of the Food and Drug Administration has given a positive review to an AstraZeneca drug used to treat schizophrenia and bipolar disorder.

The Anglo-Swedish drug maker announced that the FDA’s Psychopharmacologic Drugs Advisory Committee had given favorable review to its supplemental approval application for Seroquel (quetiapine fumarate). AstraZeneca is seeking approval for the drug as a treatment for schizophrenia in adolescents ages 13 to 17 and bipolar mania in children and adolescents ages 10 to 17.

“We are pleased that the committee found Seroquel to be effective and acceptably safe for treating adolescents with schizophrenia and children and adolescents with biopolar mania, and we look forward to having further discussions with the FDA regarding the sNDAs,” AstraZeneca chief medical officer Howard Hutchinson said in a statement, referring to the company’s supplemental new drug applications.

The same day the advisory committee made its decision about Seroquel, it also voted in favor of Eli Lilly & Co.’s Zyprexa (olanzapine) as a treatment for schizophrenia and bipolar episodes in adolescents, ages 13 to 17.

The committee’s decisions do not constitute approval, but the FDA takes them into consideration when deciding whether to approve a drug.

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