Posted by Michael Wonder on 01 Dec 2021
BioXcel Therapeutics announces extension of FDA review period of its NDA for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders
1 December 2021 - PDUFA date extended by three months to 5 April 2022.
BioXcel Therapeutics today announced that the U.S. FDA has extended the Prescription Drug User Fee Act date for its review of the new drug application of BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II.
