Pharma Major Lupin Limited (Lupin) announced that it has received final approval for Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg from the United States Food and Drug Administration (FDA) to market a generic version of Janssen Pharmaceuticals, Inc.’s Ortho-Cyclen® 28 Tablets (Norgestimate/Ethinyl Estradiol). The approved product will be manufactured at Lupin’s Pithampur facility.
Lupin’s Norgestimate and Ethinyl Estradiol Tablets USP, 0.25 mg/0.035 mg are the AB rated generic equivalent of Janssen Pharmaceuticals, Inc.’s Ortho-Cyclen® 28 Tablets (Norgestimate/Ethinyl Estradiol). It is indicated for use by females of reproductive potential to prevent pregnancy.
Ortho-Cyclen® Tablets had US sales of USD 178.2 million (IMS MAT June 2016).
