Warnings, Columns-Drugs & Supplements, July 2005
July 7, 2005
| FDA Doesn't Approve J&J's Risperdal for Alzheimer's or Autism RARITAN, N.J. - Johnson & Johnson Pharmaceutical Research & Development announced in May that the Food and Drug Administration declined to approve its Supplemental New Drug Application for its antipsychotic drug, Risperdal®. Risperdal (risperidone) is currently used to treat bipolar mania. J&J applied the drug for approval in the treatment of psychosis of Alzheimer's disease and in the treatment of autism. The company said it is evaluating the FDA's letter and 'will determine the appropriate next steps.' |
FDA Approves New Labeling and Distribution Program for Iressa
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