Pharma major Lupin Ltd on Friday said it has received approval from the U.S. health regulator to market its generic 'Minzoya' tablets used to prevent pregnancy.
The approval granted by the U.S. Food and Drug Administration is for the abbreviated new drug application for Minzoya (Levonorgestrel and Ethinyl Estradiol tablets, and Ferrous Bisglycinate tablets) of strengths 0.1 mg/0.02 mg and 36.5 mg, Lupin said in a regulatory filing.
The drug is 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, it added.
The product will be manufactured at Lupin's Pithampur facility in India, the company said.
Minzoya tablets are indicated for use by females of reproductive potential to prevent pregnancy.
Levonorgestrel and Ethinyl Estradiol tablets, and Ferrous Bisglycinate tablets had estimated annual sales of $42 million in the U.S., the company said citing IQVIA MAT December 2023 data.
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