Lupin Limited today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Brexpiprazole Tablets, via an exchnahge filing.
The approved dosages are 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, a generic equivalent of Rexulti Tablets of Otsuka Pharmaceutical Company Ltd.
This product would be manufactured at Lupin’s Pithampur facility in India.
Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of USD 1,575 million in the U.S. (IQVIA MAT December 2022)
