Pharma major Lupin 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 (USFDA) 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 $ 178.2 million as per IMS MAT June 2016.
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.
