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23 October, 2018 20:14 IST
Lupin receives USFDA approval for pregnancy prevention tablets
Source: IRIS | 14 Jun, 2018, 03.47PM
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Pharma major Lupin announced that it has received final approval fonts Drospirenone, Ethinyl Estradiol, Levomefolate Calcium Tablets and LevomefolateCalcium Tablets, 3 mg/0.02 mg/0.451 mg and 0.451 mg, from the United States Food and Drug Administration (FDA) to market a generic version of Bayer HealthCare Pharmaceutical Inc.'s (Bayer) Beyaz®Tablets.

Lupin's Drospirenone, Ethinyl Estradiol, Levomefolate Calcium Tablets and Levomefolate Calcium Tablets, 3 mg/0.02 mg/0.451 mg and 0.451 mg, are the generic equivalent of Bayer's Beyaz® Tablets. It is indicated for use by women to:

> prevent pregnancy;

> treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception;

> treat moderate acne for women at least 14 years old, only if the patient desires an oral contraceptive for birth control; and

> raise folate levels in women who choose to use an oral contraceptive for contraception

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 approximately U5D 82.2 million in the US (IOWA MATApril 2018).

Shares of the company gained Rs 47.7, or 5.58%, to trade at Rs 902.00. The total volume of shares traded was 391,151 at the BSE (3.30 p.m., Thursday).





Lupin Limited   (Q,N,C,F)*

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