Dr Reddy's, Others Get USFDA Nod for Schizophrenia Drug
Thursday, 27 October 2011, 00:01 IST
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Hyderabad:US Food and Drug Administration (USFDA) has approved the first generic versions of Zyprexa and Zyprexa Zydus, used for treating schizophrenia and bipolar disorder, to be made by Dr Reddy's Laboratories (DRL) and others. Generic olanzapine tablets will be manufactured by DRL and Teva Pharmaceuticals USA, and the Generic olanzapine orally disintegrating tablets will be manufactured by Apotex, DRL and Par Pharmaceuticals, the FDA said. Olanzapine, which is currently being marketed under the brand Zyprexa by Eli Lilly, is seen having sales of $5.3 billion worldwide with nearly half of it from the US alone, according to Eli Lilly. Schizophrenia is a chronic, severe, and disabling brain disorder. About 1% of Americans are said to be suffering from 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hearing voices, believing other people are reading their minds or controlling thoughts, and being suspicious or withdrawn. The approval of the generic olanzapine offers greater access to a widely used treatment for mental illnesses, said 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." Webber said in a statement. Generic drugs approved by USFDA 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, the USFDA said. In 2009, a UK appeals court had upheld the validity of Eli Lilly patent for Zyprexa and rejected Dr Reddy's contention that an earlier Lilly patent rendered patent for the blockbuster drug for schizophrenia invalid.
Source: PTI
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