Posted by Michael Wonder on 13 Sep 2022
Otsuka and Lundbeck announce U.S. FDA acceptance of new drug application for aripiprazole 2 month, ready to use, long-acting injectable to treat schizophrenia and bipolar I disorder in adults
13 September 2022 - Filing is supported by a 32 week bridging trial in which aripiprazole 2 month showed comparable effectiveness and consistent safety profile to aripiprazole 1 month.
Otsuka and Lundbeck announce the US FDA acceptance of their new drug application for aripiprazole 2 month, ready to use, long-acting injectable, a medication administered for the treatment of schizophrenia in adults and for maintenance monotherapy treatment of bipolar I disorder in adults.
