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FDA Approves First Generic Olanzapine to treat Schizophrenia, Bipolar Disorder

FDA Approves First Generic Versions of Zyprexa and Zyprexa Zydis

The U.S. Food and Drug Administration today approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydis (olanzapine orally disintegrating tablets) to treat schizophrenia and bipolar disorder.

Schizophrenia is a chronic, severe, and disabling brain disorder. About 1 percent of Americans have this illness. Symptoms people with schizophrenia have include: hearing voices, believing other people are reading their minds or controlling thoughts, and being suspicious or withdrawn.

Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. The symptoms of bipolar disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep.

“The approval of generic olanzapine offers greater access to a widely used treatment for mental illnesses,” said Keith Webber, Ph.D., deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research. “Having affordable treatment options is good for patients with long-term illnesses that must be carefully managed.”

Olanzapine must be dispensed with a Medication Guide that describes the risks and adverse reactions people should be mindful of when using the product. Olanzapine has a boxed warning alerting that this type of drug can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Olanzapine is not approved for treating psychosis in the elderly with dementia.

Other serious risks of olanzapine include, high blood sugar (hyperglycemia), high-lipid levels in the blood (increased cholesterol and triglycerides), and weight gain. Clinicians should take these effects into account when deciding to use this type of medication.

Generic drugs approved by FDA have the same high quality, strength, purity, and stability as brand-name drugs. The generic manufacturing, packaging, and testing sites must pass the same quality standards as those of brand name drugs.

Generic olanzapine tablets will be manufactured by Dr. Reddy’s Laboratories Ltd. and Teva Pharmaceuticals USA. Generic olanzapine orally disintegrating tablets will be manufactured by Apotex Inc., Dr. Reddy’s Laboratories Ltd., and Par Pharmaceuticals Inc.

SOURCE:

FDA

October 25, 2011



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