NEW DELHI: The United States Food and Drug Administration (US FDA) has on Friday granted approval for drugmaker Lupin's Minzoya tablets to prevent pregnancy.
The pharma giant was granted 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.
This will enable Lupin to manufacture and 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, the company noted in a regulatory filing.
Minzoya tablets are indicated for use by females of reproductive potential to prevent pregnancy.
Citing IQVIA MAT December 2023 data, the company noted that Levonorgestrel and Ethinyl Estradiol tablets, and Ferrous Bisglycinate tablets had estimated annual sales of $42 million in the US.