Lupin has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Turqoz (Norgestrel and Ethinyl Estradiol Tablets USP) 0.3 mg/0.03 mg, to market a generic equivalent of Lo/Ovral-28 (Norgestrel and Ethinyl Estradiol Tablets) 0.3 mg/0.03 mg of Wyeth Pharmaceuticals.
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 $34 million in the US (IQVIA MAT Mar 2023).