Instant Report
FDF

Date: 08-Oct-2021

Lupin Receives US FDA Approval For Generic Rexulti Tablets

Global pharma major Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) brexpiprazole tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, to market a generic equivalent of Rexulti tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, of Otsuka Pharmaceutical Co., Ltd.

This product will be manufactured at Lupin’s Pithampur facility in India.

Brexpiprazole tablets had estimated annual sales of US$ 1,258 million in the US, according to IQVIA MAT July 2021