Janssen Reports sNDA Submission of Paliperidone Palmitate 6-Month (PP6M) to the US FDA for Schizophrenia
Shots: The sNDA submission is based on P-lll Route-6 study assessing PP6M vs PP3M in 702 patients with schizophrenia previously stabilized on corresponding doses of PP1M or PP3M across 20 countries Results demonstrated non-inferior efficacy of PP6M to PP3M on the 1EPs of time to relapse at the end of the 12mos. period in both […]