The drug has received US FDA approval earlier
Lupin has launched Drospirenone, Ethinyl Estradiol, Levomefolate Calcium Tablets and Levomefolate Calcium Tablets, 3 mg/0.02 mg/0.451 mg and 0.451 mg (EQ Beyaz), having received an approval from the United States Food and Drug Administration (US FDA) earlier.
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 and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets, 3 mg/0.02 mg/0.451 mg and 0.451 mg had annual sales of approximately $80.8 million in the US (IQVIA MAT June 2018).
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