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).