Intra-Cellular Therapies Inc.’s (ITCI) supplemental new drug applications for Lumateperone are under FDA review, with a decision expected on December 17.The company is seeking approval of Lumateperone for the treatment of depressive episodes associated with bipolar I or II disorder as monotherapy and as adjunctive therapy in adults.Lumateperone, under brand name Caplyta, is already approved by the FDA for the treatment of schizophrenia in adults. Launched in March 2020, the drug generated sales of $22.53 million last year and $56.2 million in the first nine months of 2021.AstraZeneca’s Seroquel and Seroquel XR are the only FDA-approved drugs for bipolar II depression.ITCI closed Friday’s trading at $42.45, down 2.55%.