Lupin's birth-control pill gets USFDA approval

Mumbai: Lupin Limited, a pharmaceutical company, has announced today that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application concerning Turqoz (Norgestrel and Ethinyl Estradiol Tablets USP) 0.3 mg/0.03 mg.

This approval allows Lupin to market a generic equivalent of Wyeth Pharmaceuticals LLC's Lo/Ovral-28 (Norgestrel and Ethinyl Estradiol Tablets) 0.3 mg/0.03 mg in the United States.

The manufacturing of this product will take place at Lupin's Pithampur facility in India. The original brand, Norgestrel and Ethinyl Estradiol Tablets USP (RLD Lo/Ovral-28), had an estimated annual sale of USD 34 million in the U.S. as of March 2023, according to IQVIA data.