WASHINGTON, July 1 (UPI) -- The U.S. Food and Drug Administration says it's approved the first generic versions of Risperdal tablets for certain psychiatric disorders.
The FDA said Risperdal (risperidone) is an anti-psychotic drug used for the treatment of schizophrenia, bipolar disorder and other psychiatric conditions.
Varying strengths of risperidone tablets, manufactured by TEVA Pharmaceuticals USA, have been approved, although the labeling of the generic risperidone might differ from that of Risperdal because some uses of the drug are protected by patents and exclusivity, the agency said.
The generic risperidone products will have the same safety warnings as Risperdal, including a boxed warning, cautioning that older patients with dementia-related psychosis treated with atypical anti-psychotic drugs are at increased risk of death, as compared with those taking placebo.
