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FDA approves Lupin’s generic Beyaz

The Food and Drug Administration has approved Lupin’s generic Beyaz (drospirenone, ethinyl estradiol, levomefolate calcium) tablets 3 mg/0.02 mg/0.451 mg.

The drug is an equivalent of Bayer’s Beyaz tablets and is indicated for use by women to prevent pregnancy, treat symptoms of premenstrual dysphoric disorder for those choosing an oral contraceptive, treat moderate acne in women at least 14 years old, and raise folate levels in those who choose an oral contraceptive.

The product had annual sales of approximately $8 million, according to IQVIA data.
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