Generic versions of olanzapine tablets (Zyprexa) and olanzapine orally disintegrating tablets (Zyprexa Zydus) for the treatment of schizophrenia and bipolar disorder have been approved by the US Food and Drug Administration (FDA). According to the FDA, approximately 1% of Americans are affected by schizophrenia. WHO (World Health Organization) says that about 1% of people worldwide have schizophrenia.
Schizophrenia is a long-term (chronic), severe and disabling brain disorder. Patients may hear voices, believe others are controlling their thoughts or reading their minds… for more information on schizophrenia go to What is Schizophrenia?.
Bipolar disorder, or manic-depressive illness is also a brain disorder. The patient has unusual shifts in energy, mood and the ability to function – these shifts can last for weeks, and even months. They are completely different from the general ups and downs everyone goes through. Symptoms are severe and can be devastating for relationships, job prospects, and academic performance.
Deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research, Keith Webber, Ph.D., said:
“The approval of generic olanzapine offers greater access to a widely used treatment for mental illnesses. Having affordable treatment options is good for patients with long-term illnesses that must be carefully managed.”
The FDA says that olanzapine must be given with a Medication Guide that explains the possible risks and side effects patients should be aware of when taking this drug. It also has a boxed warning which explains that this kind of medication increases the risk of death if used to treat psychosis in elderly patients with dementia. Olanzapine is not FDA-approved for treating psychosis among elderly people with dementia.
Other adverse events linked to olanzapine usage include weight gain, hyperglycemia (high blood glucose), and increased cholesterol and triglyceride levels. When determining whether to prescribe olanzapine, doctors should consider these risks.
The FDA stresses that FDA-approved generic medications are as good as brand-name ones. They are made to the same high quality, strength, stability and purity as the brand name. All specifications and tests regarding manufacturing, packaging and testing of generic products are the same as they are for brand name ones.
Dr. Reddy’s Laboratories Ltd. and Teva Pharmaceuticals will manufacture olanzapine tablets while Apotex Inc., Dr. Reddy’s Laboratories Ltd., and Par Pharmaceuticals Inc. will produce generic olanzapine orally disintegrating tablets.
Olanzapine is known under many brand names, including Zyprexa, Zypadhera, Oferta, Zolafren, Olzapin and Zalasta. Its molecular formula is C17H20N4S. It is an atypical antipsychotic, FDA approved for the treatment of bipolar disorder and schizophrenia. It is structurally similar to clozapine, but is classed as a thienobenzodiazepine. The brand names are manufactured and marketed by Eli Lilly. A judge in Canada ruled in 2009 that the 1991 patent for olanzapine was invalid. In 2008, Zyprexa sales worldwide reached $4.7 billion ($2.2 billion in the USA).
Written by Christian Nordqvist