Lupin receives tentative U.S. FDA Approval for Brivaracetam 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) Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, to market a generic equivalent of Briviact® Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, of UCB Inc. This product will be manufactured at Lupin's Nagpur facility in India.

Brivaracetam Tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older.

Brivaracetam Tablets (RLD: Briviact® Tablets) had estimated annual sales of USD 311 million in the U.S. (IQVIA MAT June 2021).

Shares of Lupin Ltd was last trading in BSE at Rs. 967 as compared to the previous close of Rs. 976.6. The total number of shares traded during the day was 95111 in over 4580 trades.

The stock hit an intraday high of Rs. 984.15 and intraday low of 958.7. The net turnover during the day was Rs. 92061102.

Source : Equity Bulls

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