Lupin gets USFDA approval for generic Ortho-Cyclen tablets

Mumbai : Pharma major Lupin Ltd has received final approval from the USFDA to market norg-estimate and ethinyl estradiol tablets marked for use by females of reproductive potential to prevent pregnancy.

"We have received final approval for norg-estimate 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 USD 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.