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 Tablets had annual sales of approximately USD 31.4 million in the US (IQVIA MAT June 2018).
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