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October 6, 2006 – The U.S. Food and
Drug Administration (FDA) today approved Risperdal (risperidone)
orally disintegrating tablets, an adult antipsychotic drug,
for the symptomatic treatment of irritability in autistic
children and adolescents. The approval is the first for the
use of a drug to treat behaviors associated with autism in
children. These behaviors are included under the general heading
of irritability, and include aggression, deliberate self-injury,
and temper tantrums.
"This approval should benefit many
autistic children as well as their parents and other care
givers," said Steven Galson, M.D., director of FDA’s
Center for Drug Evaluation and Research. "Our agency
strongly encourages the development of appropriate pediatric
labeling for adult drugs, and Risperdal is a welcome addition
to the growing number of such products that have been shown
to have an appropriate risk-benefit profile when tested in
children."
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