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First generic versions of Zyprexa receive market clearance.

WASHINGTON -- The Food and Drug Administration has approved the first generic versions of Zyprexa (olanzapine tablets) and Zyprexa Zydus (olanzapine orally disintegrating tablets) to treat schizophrenia and bipolar disorder.

Schizophrenia is a chronic, severe and disabling brain disorder. About 1% of Americans have this illness. Symptoms people with schizophrenia have include heating voices, believing other people are reading their minds or controlling thoughts, and being suspicious or withdrawn.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. 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," comments Keith Webber, 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 guide that describes the risks and adverse reactions that 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).

According to the regulatory agency, other serious risks of olanzapine include high blood sugar (hyperglycemia), high lipid levels in the blood (increased cholesterol and triglycerides) and weight gain.

Among those generic drug manufacturers introducing olanzapine tablets USP is Teva Pharmaceuticals USA. Its product is available in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg strengths.

"Our global investment in new product development continues to pay dividends," states Maureen Cavanaugh, Teva's vice president of customer operations and marketing. "Our vertical integration provides us with a strategic advantage that ensures that customers have a consistent, reliable source of the products they need."

Teva's olanzapine tablets in 2.5 mg, 5 mg, 7.5 mg, 10 mg and 15 mg strengths and Dr. Reddy's Laboratories LTD's product in 20 mg have each been awarded a 180-day period of marketing exclusivity in the United States. Dr. Reddy's is supplying the 20 mg version of the product following an April 2011 commercialization, manufacture and supply agreement with Teva.

In addition, as per terms of that agreement, Dr. Reddy's will launch its 2.5 mg, 5 mg, 7.5 mg, 10 mg ,15 mg and 20 mg of olanzapine tablets upon expiration of that six month exclusivity period.

Besides its action on olanzapine, the FDA granted Sun Pharmaceutical Industries Ltd. an approval for its ANDA to market a generic version of Cardizem CD (diltiazem HC1 extended-release capsules.) These generic capsules are equivalent to Valeant International's Cardizem CD, 120 mg, 180 mg, 240 mg, 300 mg and 360 mg. Annual sales in the United States for these strengths is about $300 million. Diltiazem HC1 extended-release capsules are indicated in the treatment of hypertension, for the management of chronic stable angina and angina due to coronary artery spasm.
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Title Annotation:RX RETAIL PHARMACY: Generic Drugs
Publication:Chain Drug Review
Date:Nov 21, 2011
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