FDA approves Lupin’s Beyaz generic
The Food and Drug Administration has approved Lupin’s Beyaz generic (drospirenone, ethinyl estradiol, levomefolate calcium tablets, 3 mg/0.02 mg and 0.451 mg, and levomefolate calcium tablets, 0.451 mg).
The drug is indicated to prevent pregnancy, treat symptoms of premenstrual dysphoric disorder, treat moderate acne for women at least 14 years old who desire and oral contraceptive and raise folate levels in women who choose an oral contraceptive. Lupin’s Beyaz generic will enter a market that saw $82.2 million in annual sales for the 12 months ended April 2018.