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  • FDA Approves First Generic Risperidone To Treat Psychiatric Conditions

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    The FDA approved the first generic versions of Risperdal (risperidone) to treat schizophrenia, bipolar disorder, and other psychiatric conditions. The generic risperidone tablets were manufactured by TEVA Pharmaceuticals USA and will carry the same safety warnings as Risperdal, including a black box warning about increased death risks in older patients with dementia. Physicians can use antipsychotics off-label to treat dementia symptoms.

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    The FDA approved the first generic versions of Risperdal (risperidone) to treat schizophrenia, bipolar disorder, and other psychiatric conditions. The generic risperidone tablets were manufactured by TEVA Pharmaceuticals USA and will carry the same safety warnings as Risperdal, including a black box warning about increased death risks in older patients with dementia. Physicians can use antipsychotics off-label to treat dementia symptoms.

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    56 tayangan2 halaman

    FDA Approves First Generic Risperidone To Treat Psychiatric Conditions

    Diunggah oleh

    pedrovsky702
    The FDA approved the first generic versions of Risperdal (risperidone) to treat schizophrenia, bipolar disorder, and other psychiatric conditions. The generic risperidone tablets were manufactured by TEVA Pharmaceuticals USA and will carry the same safety warnings as Risperdal, including a black box warning about increased death risks in older patients with dementia. Physicians can use antipsychotics off-label to treat dementia symptoms.

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    Attribution Non-Commercial (BY-NC)
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    FDA Approves First Generic Risperidone To Treat Psychiatric Conditions


    03 Jul 2008
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    The U.S. Food and Drug Administration approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions. "This generic drug approval is another example of the FDA's efforts to increase access to safe and effective generic drugs as soon as the law permits," said Gary Buehler, director of the FDA's Office of Generic Drugs in the Center for Drug Evaluation and Research. Varying strengths of risperidone tablets, manufactured by TEVA Pharmaceuticals USA, have been approved. Specific information about the strengths approved can be found here. The labeling of the generic risperidone may differ from that of Risperdal because some uses of the drug are protected by patents and exclusivity. The generic risperidone products will have the same safety warnings as Risperdal, including a Boxed Warning that cautions that older patients with dementia-related psychosis treated with atypical antipsychotic drugs are at increased risk of death compared with those taking placebo. Risperdal, and other antipsychotic medications, are not FDA-approved to treat dementia-related psychosis. The decision to use antipsychotic medications in the treatment of patients with symptoms of dementia is left to the discretion of the physician. Such use is often called "off-label" use and falls within the practice of medicine. http://www.fda.gov

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    Citations: Please use one of the following formats to cite this article in your essay, paper or report: MLA U.S. Food and Drug Administration. "FDA Approves First Generic Risperidone To Treat Psychiatric Conditions." Medical News Today. MediLexicon, Intl., 3

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    09/10/2013

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    Jul. 2008. Web. 9 Oct. 2013. <http://www.medicalnewstoday.com/releases/113701.php> APA U.S. Food and Drug Administration. (2008, July 3). "FDA Approves First Generic Risperidone To Treat Psychiatric Conditions." Medical News Today. Retrieved from http://www.medicalnewstoday.com/releases/113701.php. Please note: If no author information is provided, the source is cited instead.

    Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions. Find us on Facebook: www.facebook.com/mntoday Weekly newsletter e-mails available at: http://www.medicalnewstoday.com/newsletters.php Send your press releases to pressrelease@medicalnewstoday.com

    http://www.medicalnewstoday.com/printerfriendlynews.php?newsid=113701

    09/10/2013

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