INDICATIONS AND USAGE
LATUDA is indicated for treatment of major depressive episodes associated with bipolar I disorder
(bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.
The efficacy of LATUDA was established in a 6-week monotherapy study and a 6-week adjunctive therapy study with lithium or valproate in adult patients with bipolar depression.
The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. The efficacy of LATUDA in the treatment of mania associated with bipolar disorder has not been established.
1. Latuda® (lurasidone HCl) prescribing information. Sunovion Pharmaceuticals Inc. July 2013.