Posted by Michael Wonder on 11 Dec 2018
Intra-Cellular Therapies announces FDA acceptance of new drug application for lumateperone for the treatment of schizophrenia
11 December 2018 - Intra-Cellular Therapies today announced that the U.S. FDA has accepted for review its new drug application for lumateperone, an investigational agent for the treatment of schizophrenia.
The FDA has assigned a Prescription Drug User Fee Act target action date of 27 September 2019.
The lumateperone submission for the treatment of schizophrenia is supported by data from 20 clinical trials and more than 1,900 subjects exposed to lumateperone. Lumateperone received fast track designation from the FDA in November 2017 for the treatment of schizophrenia.
