Lupin gets approval from US FDA for Brexpiprazole Tablets

Lupin announced that the United States Food and Drug Administration (US FDA) has approved its Abbreviated New Drug Application for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, a generic equivalent of Otsuka Pharmaceutical Company’s Rexulti Tablets. Lupin’s Pithampur facility in India would manufacture this product. Brexpiprazole Tablets (RLD Rexulti), 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, had an estimated annual sales of USD 1,575 million in the United States (IQVIA MAT December 2022).