Lupin gets USFDA tentative approval for generic Nudovra

Mumbai: Pharma major 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 version of Bayer HealthCare Pharmaceuticals Inc.’s Natazia® Tablets.

It is an estrogen/progestin combined oral contraceptive (COC), indicated for use by women to prevent pregnancy.

Clobetasol Propionate Cream USP 0.05% had annual sales of approximately USD 108.6 million in the US (IQVIA MAT June 2018).

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).