New Delhi: Lupin has received final approval from the US health regulator for marketing Norgestimate and Ethinyl Estradiol tablets, used for the prevention of pregnancy, in the US market.
The company has received final approval from the United States Food and Drug Administration (USFDA) to market its Norgestimate and Ethinyl Estradiol tablets USP, 0.25 mg/0.035 mg, Lupin said in a filing to BSE.
The company’s product is a generic version of Janssen Pharmaceuticals Inc’s Ortho-Cyclen 28 tablets, it added.
“The approved product will be manufactured at Lupin’s Pithampur facility,” the company said.
Ortho-Cyclen tablets had US sales of $178.2 million as per IMS MAT June 2016 data, it added.
Lupin Ltd stock was trading down by 0.73 per cent at Rs. 1,502 on the BSE.