Lupin’s Safyral generic Tydemy gets FDA nod

The Food and Drug Administration has approved Mumbai-based Lupin’s Tydemy. The product is a generic version of Bayer’s Safyral (drospirenone, ethinyl estradiol, and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg).

Tydemi is indicated as a contraceptive against pregnancy. The product had U.S. sales of approximately $22.9 million for the 12 months ended October 2017, according to data from IQVIA