Posted by Michael Wonder on 07 Jan 2022
Otsuka and Lundbeck announce FDA approval of supplemental new drug application for Rexulti (brexpiprazole) to treat schizophrenia in paediatric patients ages 13-17
6 January 2022 - Otsuka and Lundbeck announce the U.S. FDA has approved the supplemental new drug application of Rexulti (brexpiprazole) for the treatment of schizophrenia in paediatric patients 13 to 17 years of age.
The FDA previously granted Priority Review for the supplemental new drug application, a designation for a drug application that, if approved, would represent a significant improvement in the safety and/or effectiveness of the treatment, diagnosis, or prevention of a serious medical condition.
