Lupin Receives Tentative Approval from U.S. FDA for Brexpiprazofe Tablets

Global pharma major lupin Limited (Lupin) today 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 wlll be manufactured at Lupln's Plthampur facility In India.

Brexpiprazole Tablets (RLD: Rexu1ti® Tablets) had estimated annual sales of USO 1258 million In the U.S. (IQVIA MAT July 2021).

Shares of Lupin Limited was last trading in BSE at Rs. 947.65 as compared to the previous close of Rs. 963.50. The total number of shares traded during the day was 125562 in over 2406 trades.

The stock hit an intraday high of Rs. 966.15 and intraday low of 941.85. The net turnover during the day was Rs. 119663325.00.

Source : Equity Bulls

Keywords

LupinLimited INE326A01037 LUPIN Pharmaceuticals ANDAApproval USFDA BrexpiprazoleTablets @LupinGlobal