FDA approves Glenmark’s generic Hailey Fe 1/20

The Food and Drug Administration has approved Glenmark Pharmaceuticals’ generic of Allergan’s Hailey Fe 1/20 norethindrone acetate, 1 mg, and ethinyl estradiol, 20 mcg) tablets.

The drug is indicated to prevent pregnancy. It had U.S. brand and generic sales of roughly $116.8 million, according to data from IQVIA for the 12 months ended September 2017.

Glenmark said that its portfolio currently consists of 129 products in the United States, with a further 58 applications pending FDA approval.