Lupin receives approval from US FDA for Brexpiprazole Tablets

Global pharma major Lupin Limited (Lupin) 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, 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).

Shares of Lupin Limited was last trading in BSE at Rs. 649.00 as compared to the previous close of Rs. 646.20. The total number of shares traded during the day was 9953 in over 922 trades.

The stock hit an intraday high of Rs. 657.00 and intraday low of 646.80. The net turnover during the day was Rs. 6461803.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Approval USFDA ANDA BrexipiprazoleTablets