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FDA Issues Non-Approvable Letter for Risperidone in the Treatment of Autism

Raritan, NJ (May 20, 2005) -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C., announced that it has received a not approvable letter from the U.S. Food and Drug Administration (FDA) regarding a Supplemental New Drug Application (sNDA) for RISPERDAL® (risperidone) in the treatment of autism.

Recognizing the unmet need in this area is great, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is evaluating the FDA's letter and will determine appropriate next steps.

Source: Johnson & Johnson Pharmaceutical Research & Development

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