Posted by Michael Wonder on 03 May 2021
Intra-Cellular Therapies announces FDA acceptance of Caplyta (lumateperone) sNDAs for the treatment of bipolar depression
3 May 2021 - Intra-Cellular Therapies today announced that the U.S. FDA has accepted for review its supplemental new drug applications for lumateperone, an investigational agent for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.
The FDA has assigned a Prescription Drug User Fee Act target action date of 17 December 2021 for the applications.
