Lupin receives tentative USFDA approval for generic Nudovra

22 Aug 2018 Evaluate

Lupin 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 (USFDA) to market a generic version of Bayer HealthCare Pharmaceuticals 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 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 around $31.4 million in the US (IQVIA MAT June 2018).

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.

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