Lupin gets USFDA nod for generic contraceptive tablets

Drug major Lupin today said it has received approval from the US health regulator to market Nudovra tablets, used to prevent pregnancy, in the American market.

The company has received tentative approval for its Nudovra (Estradiol Valerate Tablets, 3 mg and 1 mg and Estradiol Valerate and Dienogest Tablets, 2 mg/2 mg and 2 mg/3 mg) tablets from the US Food and Drug Administration (FDA), Lupin said in a statement.

The company's product, which is an estrogen/progestin combined oral contraceptive (COC) indicated for use by women to prevent pregnancy, is a generic version of Bayer HealthCare Pharmaceuticals Inc's Natazia tablets. As per IQVIA MAT June data, Nudovra tablets had annual sales of around USD 31.4 million in the US.