Marketed by Janssen, L. P. (12381409), RISPERDAL® (risperidone) is approved in the United States for the treatment of acute manic or mixed episodes of Bipolar I Disorder and for the treatment of schizophrenia in adults.
Also, RISPERDAL® was approved in the U.S. in October 2006 for the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods, in children and adolescents (ages 5 to 16 years) – the first FDA approved medication for use in children and adolescents with autism.
Now, following studies conducted in bipolar 1 disorder and schizophrenia, the USFDA has granted pediatric exclusivity to RISPERDAL®.
Find more details from the press release.
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