Glenmark gets FDA OK for Hailey, Hailey Fe

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Glenmark gets FDA OK for Hailey, Hailey Fe

By David Salazar - 06/12/2018
The Food and Driug Administration has approved two birth control products for Glenmark’s branded generics of Loestrin 21 and Loestrin Fe 1.5/30. The company’s Hailey (norethindrone acetate and ethinyl estradiol tablets 1.5 mg/30 mcg) and Hailey Fe (norethindrone acetate and ethinyl estradiol tablets, 1.5 mg) USP and ferrous fumarate tablets, 1.5 mg/30 mcg) are indicated to prevent pregnancy in women.

Hailey will enter a market whose size was roughly $24.2 million for the 12 months ended April 2018, and Hailey Fe will enter a roughly $41.3 million market for the 12 months ended April 2018, according to IQVIA data. Glenmark said it currently has 61 generic applications pending before the FDA.

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