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In a significant development, the United States Food and Drug Administration (US FDA) granted approval on Friday for Lupin, a leading pharmaceutical company, to market its Minzoya tablets for pregnancy prevention.
Lupin received the green light for its abbreviated new drug application for Minzoya, which comprises Levonorgestrel and Ethinyl Estradiol Tablets, USP, along with Ferrous Bisglycinate Tablets, in strengths of 0.1 mg/0.02 mg and 36.5 mg, respectively.
This approval enables Lupin to manufacture and 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, originally developed by Avion Pharmaceuticals LLC.
Lupin indicated that the product will be manufactured at its state-of-the-art facility in Pithampur, India, according to a regulatory filing.
Minzoya tablets are specifically intended for use by females of reproductive potential to prevent pregnancy, expanding contraceptive options available in the market.
Highlighting the potential market impact, Lupin referenced IQVIA MAT December 2023 data, which estimated annual sales of Levonorgestrel and Ethinyl Estradiol tablets, along with Ferrous Bisglycinate tablets, at a substantial $42 million in the United States.
The approval of Minzoya tablets underscores Lupin’s commitment to providing accessible and affordable healthcare solutions, reinforcing its position in the global pharmaceutical landscape.
Lupin, with its dedication to innovation and quality, continues to make strides in addressing critical healthcare needs worldwide. The approval of Minzoya tablets marks another milestone in the company’s journey towards enhancing patient care and well-being.
