FDA Approves Allergan and Gedeon Richter
September 17, 2015 – The U.S. Food and Drug Administration (FDA) approved Vraylar (cariprazine) capsules, manufactured by Allergan and Gedeon Richter. Vraylar is an atypical antipsychotic indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder, also known as manic depressive illness, and for treatment of schizophrenia in adults. Common side effects of Vraylar that were reported during the clinical studies were extrapyramidal symptoms and akathisia. Others like dyspepsia, vomiting, somnolence, and restlessness were also noted in bipolar I treatment. Recommendation for dosing ranges from 3mg to 6mg per day for bipolar I disorder and from 1.5mg to 6mg per day for schizophrenia. Boxed warning for Vraylar due to increased mortality in elderly patients with dementia-related psychosis.
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