Glenmark receives ANDA approval for Norethindrone Acetate, Ethinyl Estradiol Tablets

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg, the generic version of Loestrin 21 1/20 Tablets of Warner Chilcott Company, LLC.

According to IMS Health sales data for the 12 month period ending November 2015, the Loestrin 21 1/20 Tablets market achieved annual sales of approximately $56.8 million.

Glenmark’s current portfolio consists of 106 products authorized for distribution in the US marketplace and 62 ANDA’s pending approval with the USFDA. 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.