If approved, paliperidone palmitate will be the first and only long-acting atypical antipsychotic that has a dosing schedule of just four times a year.
Schizophrenia is a complex and chronic brain disorder and affects around 2.4 million adults in the US, often beginning in the late teens or early 20s.
Janssen Research & Development global head Neuroscience Therapeutic Area Husseini Manji said: "If approved, this three-month formulation adds an unprecedented treatment option to help address the needs of people living with schizophrenia by providing a new, less frequently dosed treatment choice.
"New treatments give patients, and caregivers, a broader range of options to address their needs as early as possible in their recovery journeys."
The NDA was based on an international, randomized, multicenter, double-blind, relapse prevention Phase III trial of paliperidone palmitate three-month injection.
More than 500 patients were included in the trial, which evaluated the efficacy of three-month paliperidone palmitate compared with placebo in delaying time to first occurrence of relapse symptoms of schizophrenia.
During the trial, patients who were randomized to treatment were stabilized with Invega Sustenna (once monthly paliperidone palmitate), an approved treatment for schizophrenia, prior to receiving the investigational three-month formulation.
The FDA has approved Invega Sustenna in 2009 as the first once-monthly atypical long-acting injection to treat schizophrenia and is currently approved in over 80 countries.