July 01, 2008

FDA Approves Generic Risperdal

TUESDAY, July 1 (HealthDay News) -- The first generic versions of the antipsychotic drug Risperdal (risperidone) were approved Monday by the U.S. Food and Drug Administration.

The generic versions in several strengths will be manufactured by Teva Pharmaceuticals USA. They will have the same boxed warnings as the brand name drug, produced by Janssen Pharmaceuticals.

The so-called "black box" warning cautions that older people with dementia-related psychosis taking this class of drug, called atypical anti-psychotics, are at increased risk of death, the FDA said. These medicines aren't approved to treat dementia-related psychosis, but doctors may legally prescribe them for that purpose under what's called "off-label" use.

"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," Gary Buehler, director of the FDA's Office of Generic Drugs, said in a statement.

The brand name drug was first approved in 1993.

More information

The FDA has more about this drug's approval history.

-- Scott Roberts

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