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Lupin gets tentative FDA green light for generic Natazia tablets

Lupin has received the Food and Drug Administration’s tentative approval for 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, an estrogen/progestin combined oral contraceptive indicated for use by women to prevent pregnancy.

The product, which is a generic version of Bayer HealthCare Pharmaceuticals’ Natazia tablets, had a market value of approximately $31.4 million, according to June 2018 IQVIA data.
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