Lupin Receives Approval from U.S. FDA for Febuxostat 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 Febuxostat Tablets, 40 mg and 80 mg, to market a generic equivalent of Uloric® Tablets, 40 mg and 80 mg, of Takeda Pharmaceuticals U.S.A., Inc. The product will be manufactured at Lupin's Pithampur facility in India.

Febuxostat Tablets, 40 mg and 80 mg, are indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.

Febuxostat Tablets (RLD Uloric®) had estimated annual sales of USD 27 million in the U.S. (IQVIA MAT November 2023).

Shares of Lupin Limited was last trading in BSE at Rs. 1425.10 as compared to the previous close of Rs. 1400.10. The total number of shares traded during the day was 70694 in over 4300 trades.

The stock hit an intraday high of Rs. 1435.15 and intraday low of 1367.45. The net turnover during the day was Rs. 99918530.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 Approval USFDA ANDA FebuxostatTablets