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Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Hailey 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol tablets USP, 1.5 mg/30 mcg) and Hailey Fe 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol tablets, USP and Ferrous Fumarate tablets, 1.5 mg/30 mcg),
The approved products are generic versions of Allergan Pharmaceuticals' Loestrin 21 1.5/30 and Loestrin Fe 1.5/30 tablets.
For the 12 months to April 2018, the Loestrin 21 1.5/30 and Leostrin Fe 1.5/30 tablets market achieved annual sales of approximately $ 24.2 million and $ 41.3 million respectively,
The company's current portfolio consists of 137 products authorised for distribution at the US marketplace and 61 Abbreviated New Drug Applications (ANDAs) pending approval with the USFDA.
