Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval from US 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 US marketplace and 59 A NDA’s pending approval with the US 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.