Mumbai: The United States Food and Drug Administration (US FDA) has given a thumbs up to Lupin Limiteds abbreviated New Drug Application (ANDA) for Brexpiprazole tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. The tablets will be produced at the Lupin factory in Pithampur, India.

The Rexulti tablets from Otsuka Pharmaceutical Company Ltd. are generically known as Brexpiprazole tablets. Rexulti tablets are an atypical antipsychotic that is indicated as adjunctive therapy to antidepressants for the treatment of the major depressive disorder (MDD) in adults as well as schizophrenia in adults and pediatric patients aged 13 years and older.

Brexpiprazole tablets had an estimated annual sales of $1,575 million in the US as per IQVIA MAT December 2022.

(Source: https://health.economictimes.indiatimes.com/news/pharma/usfda-approves-lupins-brexpiprazole-tablets-for-schizophrenia-and-depression/98894725 )