WebMD Medical News
Laura J. Martin, MD
Oct. 25, 2011 -- The FDA has approved the first generic versions of the drugs Zyprexa and Zyprexa Zydis for the treatment of schizophrenia and bipolar disorder.
The brand-name drugs are now made by Eli Lilly & Co. The generic name for the two drugs is olanzapine.
The generic will come in two forms: olanzapine tablets and a form of olanzapine that dissolves in the mouth.
Teva Pharmaceuticals USA and Dr. Reddy's Labs will manufacture olanzapine tablets. The dissolving version will be made by Dr. Reddy's, Apotex, and Par Pharmaceutical Companies.
Keith Webber, PhD, deputy director of the FDA's Office of Pharmaceutical Science, says the approval of generic olanzapine "offers greater access to a widely used treatment for mental illness."
He says that having "affordable treatment options is good for patients with long-term illnesses that must be carefully managed."
Zyprexa can cost more than $300 a month, while generic versions can substantially cut the cost.
Zyprexa is part of a class of medications called atypical antipsychotics, which affect levels of the brain chemicals that influence behavior, mood, and movement.
Generic versions of medications are approved by the FDA after the patent on the original drug expires or has been ruled invalid by courts. Approved generic drugs must have the same quality, strength, purity, and stability as the brand-name drugs.
Olanzapine carries a warning that the drug can cause death among elderly people who have psychosis due to memory loss and confusion.
Schizophrenia is a chronic, severe, and disabling brain disorder that affects about 1% of Americans.
People with schizophrenia have symptoms that include hearing voices and thinking other people are reading their minds or controlling their thoughts. The disease also causes extreme suspiciousness, and patients often become withdrawn.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 routine, day-to-day tasks.
Symptoms include alternating periods of depression and feeling elated, and increased activity and restlessness, racing thoughts, fast talking, impulsive behavior, and a decreased need for sleep.
The FDA says olanzapine must be dispensed with a medication guide that describes the risks and possible adverse reactions patients may experience. Olanzapine is not approved for treating psychosis in the elderly with dementia.
The drug can have side effects leading to high blood sugar and high blood fat levels and weight gain.
SOURCES:News release, FDA.News release, Prasco Laboratories.
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