Last Updated on December 24, 2023 by The Health Master
Global pharma major Lupin Limited announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Turqoz (Norgestrel and Ethinyl Estradiol tablets) 0.3 mg/0.03 mg.
This drug approval is to market a generic equivalent of Lo/Ovral-28 (Norgestrel and Ethinyl Estradiol tablets) 0.3 mg/0.03 mg of Wyeth Pharmaceuticals LLC.
Norgestrel and Ethinyl Estradiol tablets are used as Birth Control Pill
This product will be manufactured at Lupin’s Pithampur facility in India.
Norgestrel and Ethinyl Estradiol tablets USP (RLD Lo/Ovral-28) had an estimated annual sale of USD 34 million in the US (IQVIA MAT March 2023).
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.
The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
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