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FDA Approves Generic Antipsychotic Drug

medsThe 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 anti-psychotic 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.

Source: U.S. Food and Drug Administration

FDA Approves Generic Antipsychotic Drug

Rick Nauert PhD

Rick Nauert, PhDDr. Rick Nauert has over 25 years experience in clinical, administrative and academic healthcare. He is currently an associate professor for Rocky Mountain University of Health Professionals doctoral program in health promotion and wellness. Dr. Nauert began his career as a clinical physical therapist and served as a regional manager for a publicly traded multidisciplinary rehabilitation agency for 12 years. He has masters degrees in health-fitness management and healthcare administration and a doctoral degree from The University of Texas at Austin focused on health care informatics, health administration, health education and health policy. His research efforts included the area of telehealth with a specialty in disease management.

APA Reference
Nauert PhD, R. (2018). FDA Approves Generic Antipsychotic Drug. Psych Central. Retrieved on February 18, 2019, from
Scientifically Reviewed
Last updated: 8 Aug 2018
Last reviewed: By a member of our scientific advisory board on 8 Aug 2018
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