Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for HAILEYTM Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/20 mcg and Ferrous Fumarate Tablets), the generic version of Loestrin®1 Fe 1/20 Tablets, of Allergan Pharmaceuticals International Limited.
According to IQVIATM sales data for the 12 month period ending September 2017, the Loestrin® Fe 1/20 Tablets market2 achieved annual sales of approximately $116.8 million
Glenmark’s current portfolio consists of 129 products authorized for distribution in the U.S. marketplace and 58 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
