Lupin receives tentative approval from U.S. FDA for Azilsartan Medoxomil 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) Azilsartan Medoxomil Tablets, 40 mg, and 80 mg to market a generic equivalent of Edarbi® Tablets, 40 mg, and 80 mg, of Arbor Pharmaceuticals, LW. This product will be manufactured at Lupin's Nagpur facility in India.

Azilsartan Medoxomil Tablets (RLD: Edarbi® Tablets) had estimated annual sales of USD 103.4 million in the U.S. (IQVIA MAT September 2021).

Shares of Lupin Limited was last trading in BSE at Rs. 912.25 as compared to the previous close of Rs. 901.05. The total number of shares traded during the day was 33584 in over 1621 trades.

The stock hit an intraday high of Rs. 914.00 and intraday low of 899.10. The net turnover during the day was Rs. 30498991.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Pharmaceuticals TentativeApproval ANDA AzilsartanMedoxomilTablets USFDA Edarbi