From rxpgnews.com
FDA Refuses Autism Drug Application
By Johnson & Johnson Pharmaceutical Research & Development,
May 21, 2005 - 10:22:38 AM
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) 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(R) (risperidone) in the treatment of autism.
Recognizing the unmet need in this area is great, J&JPRD is evaluating the FDA's letter and will determine appropriate next steps.
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