Lupin receives approval from U.S. FDA for Minzoya™

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 Minzoya™ (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets), 0.1 mg/0.02 mg and 36.5 mg, to market a generic equivalent of Balcoltra®(Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets) 0.1 mg/0.02 mg and 36.5 mg, of Avion Pharmaceuticals LLC. The product will be manufactured at Lupin's Pithampur facility in India.

Minzoya™ Tablets are indicated for use by females of reproductive potential to prevent pregnancy.

Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets (RLD Balcoltra®) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT December 2023).

Shares of Lupin Limited was last trading in BSE at Rs. 1620.65 as compared to the previous close of Rs. 1605.15. The total number of shares traded during the day was 40247 in over 2818 trades.

The stock hit an intraday high of Rs. 1638.00 and intraday low of 1598.15. The net turnover during the day was Rs. 65174059.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 USFDA Approval ANDA Minzoya