Glenmark Pharma gets USFDA nod for generic version of Loestrin 24 Fe Tablets

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Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for HAILEY 24 Fe(Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 mg/20 mcg, the generic version of Loestrin 24 Fe Tablets, of Allergan Pharmaceuticals International Ltd.

According to IQVIA sales data for the 12 month period ending September 2017, the Loestrin 24 Fe Tablets market achieved annual sales of approximately $96.7 million*.

Glenmark’s current portfolio consists of 128 products authorized for distribution in the U.S. marketplace and 59 ANDA’s pending approval with the U.S. FDA.