Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for MinzoyaTM (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 Eth vinyl Estradiol Tablets., USP and Ferrous Bis glycinate Tablets) 0.1mg/0.02 mg and36.5 mg, of Avion Pharmaceuticals LLC. The product will be manufactured at Lupin's Pithampur facility in India.

MinzoyaTM Tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and ethinyl Estradiol Tablet, USP and Ferrous bisglycinate Tablets (RLD Balcoltra®?) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT December 2023).