Medical News Today News Article - Printer Friendly

Página 1 de 2

FDA Approves First Generic Risperidone To Treat Psychiatric Conditions
03 Jul 2008
Click to Print

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.

References: There are no references listed for this article.

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


For more information. July 3).com/releases/113701. Web. Retrieved from http://www.Printer Friendly Página 2 de 2 Jul.medicalnewstoday. 9 Oct. Please note: If no author information is Send your press releases to Weekly newsletter e-mails available at: http://www.php?newsid=113701 09/10/2013 . 2013. please read our terms and conditions. Find us on Facebook: www.Medical News Today News Article .com http://www.medicalnewstoday. < the source is cited instead. "FDA Approves First Generic Risperidone To Treat Psychiatric Conditions.medicalnewstoday. 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. Food and Drug Administration. (2008.php." Medical News Today. 2008.S.php> APA