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Lupin gets USFDA approval for generic contraceptive drug 14/06/2018 16:32

Drug maker Lupin today said it has received approval from the US health regulator to market Drospirenone, Ethinyl Estradiol, Levomefolate Calcium tablets, used to prevent pregnancy, in the American market.

The company has received final approval from the United States Food and Drug Administration (FDA) to market its product which is a generic version of Bayer HealthCare Pharmaceutical Inc's Beyaz tablets, Lupin said in a statement.

The product is indicated for use by women to prevent pregnancy and treat symptoms of premenstrual dysphoric disorder (PMDD).

The drug is also used to treat moderate acne for women at least 14 years old besides to raise folate levels in women who choose to use an oral contraceptive for contraception.

According to IQVIA MAT April 2018 data, Drospirenone, Ethinyl Estradiol, Levomefolate Calcium Tablets and Levomefolate Calcium Tablets, 3 mg/0.02 mg/0.451 mg and 0.451 mg had annual sales of around USD 82.2 million in the US.

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