FDA approval for Lupin’s Minzoya
India-based generic drugmaker Lupin Limited (BSE: 500257) has received approval from the US Food and Drug Administration (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 of USA-based specialty drugmaker Avion Pharmaceuticals.
Minzoya Tablets are indicated for use by females of reproductive potential to prevent pregnancy, and the product will be manufactured at Lupin’s Pithampur facility in India.
Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets( RLD Balcoltra) had estimated annual sales of $42 million in the USA, according to IQVIA (MAT December 2023).
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