Pharma major Lupin Ltd has received final approval from the USFDA to market norgestimate and ethinyl estradiol tablets marked for use by females of reproductive potential to prevent pregnancy.
“We have 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 Ortho-Cyclen 28 tablets,” a company statement said today.
The approved product will be manufactured at Lupin’s Pithampur facility. It is indicated for use by females of reproductive potential to prevent pregnancy. Ortho-Cyclen tablets had US sales of $178.2 million.
Lupin is an innovation-led transnational pharmaceutical company developing and delivering a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.