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Lupin gets USFDA tentative approval for generic Nudovra


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).

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Ruby Khatun

Ruby Khatun

Ruby Khatun joined Medical Dialogue as Reporter in 2016. She covers all the business news in different categories. She also covers all the updates in Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a post graduate from Jamia Hamdard. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751


Source: Press Release
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