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Adult patients with schizophrenia: akathisia Pediatric patients (13 to 17 years with schizophrenia: extrapyramidal disorder, somnolence, and tremor Adult patients (monotherapy with bipolar mania: akathisia, sedation, restlessness, tremor, and extrapyramidal disorder Adult patients (adjunctive therapy with lithium or valproate with bipolar mania: akathisia, insomnia, and extrapyramidal disorder Pediatric patients (10 to 17 years with bipolar mania: somnolence, extrapyramidal disorder, fatigue, nausea, akathisia, blurred vision, salivary hypersecretion, and dizziness Adult patients with major depressive disorder (adjunctive treatment to antidepressant therapy): akathisia, restlessness, insomnia, constipation, fatigue, and blurred vision Pediatric patients (6 to 17 years with autistic disorder: sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy Pediatric patients (6 to 18 years with Tourette’s disorder: sedation, somnolence, nausea, headache, nasopharyngitis, fatigue, increased appetite Adult patients with agitation associated with schizophrenia or bipolar mania: nausea.
In clinical trials, Abilify was tested against placebo-controlled groups in acutely relapsed patients with schizophrenia. Three of the four short-term trials were able to distinguish Abilify from placebo. However, in the smallest study, the trials were unable to distinguish Abilify from placebo.
The FDA has approved the first drug with a digital ingestion tracking system. Abilify MyCite is an antipsychotic with an ingestible sensor that transmits data to a patch, which then sends the information to a smartphone app. Proteus Digital Health hide caption.
The Abilify MDL will take place in Florida and will be presided under the Honorable Margaret C. Rodgers. Cases will now transfer from their original jurisdiction to a courthouse in Florida until legal proceedings are completed.
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