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FDA approves expanded use of antipsychotic drug


ADELPHI, Md. An advisory committee of the Food and Drug Administration has voted that a drug used to treat bipolar disorder and schizophrenia is safe for use in teenagers.

Indianapolis-based drug maker Eli Lilly & Co. announced that the FDA’s Psychopharmacologic Drugs Advisory Committee voted that Zyprexa (olanzapine) is effective and acceptably safe for treating schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents, ages 13 to 17.

“This committee of experts spent two days discussing the science of a difficult topic being debated in the media, doctors’ offices and living rooms across the country,” Lilly Research Labs VP John Hayes said. “Today’s committee vote is an important step toward providing help and hope to the many teens suffering from severe mental illness.”

The committee voted 11 to five with two abstentions for the schizophrenia indication and 10 to four with four abstentions for the bipolar disorder indication. FDA advisory committees’ votes do not grant approval to drugs, but they are taken into consideration when the FDA decides whether to approve a drug.

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