Lupin gets US FDA approval for Norgestrel and Ethinyl Estradiol Tablets USP

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).