FDA Approves First Generic Versions of Olanzapine

Caroline Cassels

October 24, 2011

October 24, 2011 — The US Food and Drug Administration (FDA) has approved the first generic versions of olanzapine (Zyprexa, Lilly) and olanzapine orally disintegrating tablets (Zyprexa Zydis) for schizophrenia and bipolar disorder (BD).

"The approval of generic olanzapine offers greater access to a widely used treatment for mental illnesses," said Keith Webber, PhD, 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 of which people should be mindful when using the product.

An atypical antipsychotic, olanzapine has a boxed warning alerting clinicians and patients that, similar to other agents in this drug class, there is an increased mortality risk in elderly patients with psychosis and dementia. Although the drug is not approved for these indications in this population, it is often used off-label.

Other serious risks of olanzapine include hyperglycemia, increased cholesterol and triglycerides, and weight gain. Clinicians should take these effects into account when deciding to use this type of medication.

According to the FDA release, "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.

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