Intra-Cellular Therapies, Inc. announced that the U.S. Food and Drug Administration (FDA) approved CAPLYTA for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate. Bipolar I and bipolar II disorder are serious, highly prevalent psychiatric chronic conditions affecting approximately 11 million adults in the U.S., characterized by recurrent episodes of mania or hypomania interposed with episodes of major depression (bipolar depression). Bipolar I and bipolar II disorder each represent about half of the overall population of patients with bipolar disorder. Bipolar depression is the most common and debilitating clinical presentation of bipolar disorder. These depressive episodes tend to last longer, recur more often, and are associated with a worse prognosis than the manic/hypomanic episodes. Bipolar depression is a significantly underserved medical need.