Lupin announced that it 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 United States Food and Drug Administration (FDA) to market a generic version of
Bayer HealthCare Pharmaceuticals Inc.'s Natazia® Tablets.
Lupin's 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 is the generic versional Bayer HealthCare Pharmaceuticals Inc.'s Natazia® Tablets. It is an estrogen/progestin combined oral contraceptive (COC), indicated for use by women to prevent pregnancy.
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 had annual sales of approximately USD 31.4 million in the US (IQVIA MAT June 2018).