Lupin gets USFDA nod for pregnancy prevention drug
Minzoya tablets are indicated for use by females of reproductive potential to prevent pregnancy.
Pharma major Lupin Ltd on Friday said it has received approval from the US health regulator to market its generic 'Minzoya' tablets used to prevent pregnancy.
The approval granted by the US Food and Drug Administration (USFDA) 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 USD 42 million in the US, the company said citing IQVIA MAT December 2023 data.
Get Latest Business News, Stock Market Updates and Videos; Check your tax outgo through Income Tax Calculator and save money through our Personal Finance coverage. Check Business Breaking News Live on Zee Business Twitter and Facebook. Subscribe on YouTube.