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FDA approves generic versions of Zyprexa

Agency announces first generic versions of schizophrenia, bipolar disorder drug

SILVER SPRING, Md. — The Food and Drug Administration has approved the first generic versions of two drugs made by Eli Lilly for treating schizophrenia and bipolar disorder, the agency said Monday.

The FDA announced the approval of generic olanzapine tablets and olanzapine orally disintegrating tablets, respectively generic versions of Lilly's Zyprexa and Zyprexa Zydus. Dr. Reddy's Labs and Teva Pharmaceuticals USA will manufacture olanzapine tablets, while Dr. Reddy's, Apotex and Par Pharmaceuticals will manufacture the orally disintegrating version.

"The approval of generic olanzapine offers greater access to a widely used treatment for mental illness," FDA Office of Pharmaceutical Science deputy director Keith Webber said. "Having affordable treatment options is good for patients with long-term illnesses that must be carefully managed."

On Thursday, Prasco Labs announced that it would partner with Lilly to make authorized generic versions of Zyprexa and Zyprexa Zydus, scheduled to launch at the same time as the generic versions. An authorized generic drug is the branded drug marketed under its generic name at a reduced price.


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