Lupin Gets USFDA Approval for Pregnancy Prevention Drug
Lupin Ltd. receives USFDA approval to market its generic 'Minzoya' tablets for pregnancy prevention. The drug is a generic equivalent of Balcoltra, with estimated annual sales of USD 42 million in the US.
New Delhi, Feb 16 (PTI) 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.
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.
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