FDA Rejects Risperdal as Alzheimer's Disease Treatment
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Contributed by Carla Sharetto| 26 May, 2005 20:36 GMT
Risperdal is an antipsychotic already approved by the FDA for the treatment of schizophrenia.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., today announced it has received a not approvable letter from the US
Food and Drug Administration (FDA) regarding a Supplemental New Drug Application (sNDA) for the use of Risperdal (risperidone) in the treatment of psychosis of Alzheimer's disease.
Recognizing that the unmet need in this area is great, J&J said, it is evaluating the FDA's letter and will determine appropriate next steps.
Risperdal is an antipsychotic already approved by the FDA for the treatment of schizophrenia.
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