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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]
FDA approved for bipolar disorder maintenance therapy, not for acute mood problems like depression or mania/hypomania. [10] The usual target dose is 100–200 mg daily, titrated to by 25 mg increments every 2 weeks. [11] Lamotrigine can cause Stevens–Johnson syndrome, a very rare but potentially fatal skin condition. [10] Carbamazepine
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.
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.
Cariprazine is used to treat patients with schizophrenia and manic, depressive, or mixed episodes associated with bipolar I disorder.In the United States it is approved for schizophrenia in adults, acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and treatment of depressive episodes associated with bipolar I disorder (bipolar depression).
Asenapine has been approved by the FDA for the acute treatment of adults with schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults. [12] In Australia asenapine's approved (and also listed on the PBS) indications include the following: [14] Schizophrenia