FDA accepts Otsuka, Lundbeck filing for long-acting schizophrenia drug, teeing up April decision date

FDA accepts Otsuka, Lundbeck filing for long-acting schizophrenia drug, teeing up April decision date

Source: 
Fierce Pharma
snippet: 

Otsuka and Lundbeck have taken a step toward approval of their two-month, ready-to-use, long-acting injectable treatment for schizophrenia and bipolar I disorder, securing FDA acceptance of the filing and an April 27 PDUFA date.