Posted by Michael Wonder on 01 Oct 2018
Intra-Cellular Therapies completes submission of new drug application for lumateperone for treatment of schizophrenia
28 September 2018 - Intra-Cellular Therapies today announced that the company has completed the rolling submission of its new drug application to the U.S. FDA for lumateperone, a once daily, oral investigational medicine with a novel mechanism of action for the treatment of schizophrenia.
The submission 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.
