Global pharma major Lupin Limited on Tuesday announced that it 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.
According to the company’s press statement, it is a generic equivalent of Lo/Ovral-28 (Norgestrel and Ethinyl Estradiol Tablets) 0.3 mg/0.03 mg of Wyeth Pharmaceuticals LLC. 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 U.S. (IQVIA MAT Mar 2023).
