Lupin receives USFDA approval for Minzoya Tablets

Lupin 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).

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