Intra-Cellular Therapies applies for FDA approval of Caplyta (lumateperone) for the treatment of bipolar depression

Intra-Cellular Therapies

22 February 2021 - If approved, Caplyta has the potential to treat the broadest range of patients with bipolar depression.

Intra-Cellular Therapies announced that it has recently submitted supplemental new drug applications to the U.S. FDA for two indications for Caplyta (lumateperone): 1) as monotherapy; and 2) as adjunctive therapy with lithium or valproate for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults.

Read Intra-Cellular Therapies press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier