Patents

FDA Grants Pediatric Exclusivity For RISPERDAL (Risperidone)

Published in Medical Letter on the CDC and FDA, March 25th, 2007

The U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for RISPERDAL(R) (risperidone), based on studies conducted in Bipolar 1 Disorder and schizophrenia. The patent is set to expire in December 2007, however, this grant will extend the period of exclusivity on risperidone through June 2008.

RISPERDAL(R) is approved in the U.S. to treat acute manic or mixed episodes of Bipolar I Disorder and for the treatment of schizophrenia in adults. It is marketed by Janssen, L.P.

In October 2006, RISPERDAL(R) was also approved in the U.S. for the treatment of irritability associated with autistic disorder, including symptoms of aggression...

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Source: Medical Letter on the CDC and FDA (2007-03-25)

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