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.
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