RISPERDAL CONSTA, RISPERIDONE, MG/VIAL, INJECTABLE;INTRAMUSCULAR, Prescription, None, Yes, No. RISPERDAL CONSTA, RISPERIDONE, 50MG/VIAL, INJECTABLE;INTRAMUSCULAR, Prescription, None, Yes, No. RISPERDAL Approval Date(s) and History, Letters, Labels, Reviews for NDA Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. RISPERDAL®. CONSTA® is not approved for use in patients with dementia-related psychosis. studies conducted to date have shown an association between chronic administration of this class of drugs.
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Titusville, N.J., May 18, - Janssen®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Applications (sNDAs) for the use of RISPERDAL® CONSTA® (risperidone) Long-Acting Treatment. “Long-acting therapies are moving to the forefront of treatment for mental illness, and the approval of RISPERDAL CONSTA for bipolar disorder is exciting now the first and only long-acting atypical antipsychotic therapy available for the treatment of schizophrenia and bipolar I disorder. Date: May 18,
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