Monday, August 4, 2008

Generic Med for Bipolar

Generic versions of Risperdal (risperidone) tablets have been approved by the U.S. Food and Drug Administration for 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.

The labeling of the generic risperidone may differ from that of Risperdal because some uses of the drug are protected by patents and exclusivity.


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