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22-Nov2017

Glenmark receives final approval for generic Loestrin Fe 1/20 Tablets

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

According to IQVIA sales data for the 12 month period ending September 2017, the Loestrin Fe 1/20 Tablets market achieved annual sales of approximately $116.8 million.

Glenmark's current portfolio consists of 129 products authorized for distribution in the US marketplace and 58 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.



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