Glenmark receives US FDA approval for HAILEYTM 24 Fe 1 mg/ 20 mcg

HAILEYTM 24 Fe is the generic version of Loestrin 1 24 Fe Tablets, of Allergan Pharmaceuticals International

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

According to IQVIATM sales data for the 12 month period ending September 2017, the Loestrin 1 24 Fe Tablets market achieved annual sales of approximately $96.7 million.

Glenmark’s current portfolio consists of 128 products authorised for distribution in the US marketplace and 59 ANDA’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.