New York-based Intra-Cellular Therapies Inc. initiated the rolling submission of its schizophrenia drug lumateperone with the U.S. Food and Drug Administration.
Under a rolling submission, the company can submit completed sections of its new drug application rather than waiting until every section of the application is completed before the entire application can be reviewed.
The company plans to complete its new drug application submission in mid-2018.
The treatment was granted the fast-track designation by the regulator in 2017.
