Posted by Michael Wonder on 19 May 2021
BioXcel Therapeutics announces FDA acceptance for filing of NDA for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II
19 May 2021 - FDA sets PDUFA action date for 5 January 2022.
BioXcel Therapeutics today announced that the U.S. FDA has accepted for filing the new drug application for BXCL501, the Company’s proprietary, investigational, orally dissolving thin film formulation of dexmedetomidine, for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II.
