Lupin receives approval from U.S. FDA for Brivaracetam 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 (ANDA) for Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, a generic equivalent of Briviact® Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, of UCB Inc. The product will be manufactured at Lupin's facility in Nagpur, India.

Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, (RLD Briviact®) had estimated annual sales of USD 420 million in the U.S. (IQVIA MAT September 2022).

Shares of Lupin Limited was last trading in BSE at Rs. 725.20 as compared to the previous close of Rs. 728.60. The total number of shares traded during the day was 15081 in over 1309 trades.

The stock hit an intraday high of Rs. 731.90 and intraday low of 718.00. The net turnover during the day was Rs. 10895497.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 USFDA ANDAApproval BrivaracetamTablets