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In light of recent evidence, olanzapine (Zyprexa) has been FDA approved as an effective monotherapy for the maintenance of bipolar disorder. [22] A head-to-head randomized control trial in 2005 has also shown olanzapine monotherapy to be just as effective and safe as lithium in prophylaxis. [23]
Lithium is the "classic" mood stabilizer, the first to be approved by the US FDA, and still popular in treatment. Therapeutic drug monitoring is required to ensure lithium levels remain in the therapeutic range: 0.6 to 0.8 or 0.8–1.2 mEq/L (or millimolar). Signs and symptoms of toxicity include nausea, vomiting, diarrhea, and ataxia. [3]
In 1970, lithium was approved by the United States Food and Drug Administration (FDA) for the treatment of bipolar disorder, which remains its primary use in the US. [ 5 ] [ 17 ] It is sometimes used when other treatments are not effective in a number of other conditions, including major depression , [ 18 ] schizophrenia , disorders of impulse ...
Lamotrigine is approved in the US for maintenance treatment of bipolar I disorder and bipolar II disorder. [25] While the anticonvulsants carbamazepine and valproate are predominantly antimanics , lamotrigine has demonstrated efficacy only in preventing or reducing the risk of recurrent depressive episodes of bipolar disorder.
Lurasidone is used to treat schizophrenia and bipolar disorder. [2] [21] In bipolar disorder, it has been studied both as a monotherapy and adjunctive treatment to lithium or valproate. [22] The European Medicines Agency approved lurasidone for the treatment of schizophrenia for people aged 13 years and older, [23] but not for bipolar disorder. [8]
FDA has prepared a guideline under 10.90(b) that provides information about how to prepare a summary. The summary required under this paragraph may be used by FDA or the applicant to prepare the Summary Basis of Approval document for public disclosure (under 314.430(e)(2)(ii)) when the application is approved.
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