An Indian pharmaceutical company has obtained final USFDA approval for its abbreviated new drug application (ANDA) for generic brexpiprazole tablets. Brexpiprazole is indicated for treating adults with major depressive disorder (MDD) as an adjunctive therapy to antidepressants and schizophrenia in adults and pediatric patients aged 13 years and older. Clinical evidence In clinical trials, a combination of brexpiprazole and antidepressant has been proven to significantly improve the Montgomery-Asberg Depression Rating Scale (MADRS) scores compared to placebo and antidepressant in MDD patients.
Similarly, brexpiprazole significantly improved the Positive and Negative Syndrome Scale (PANSS) scores compared to a placebo in schizophrenia patients. Dosage and administration Once daily, with or without food MDD adults – 2mg/day Schizophrenia adults – 2 to 4 mg/day Schizophrenia Pediatric…
