Glenmark's US Subsidiary Receives ANDA Approval for Two Drugs
Glenmark Pharmaceuticals Inc., USA has been granted final approval by the US FDA for its Hailey 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1.5 mg/30 mcg), the generic version of Loestrin 21 1.5/30 Tablets, of Allergan Pharmaceuticals International Ltd. and for Hailey Fe 1.5/30 (Nor ethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, 1.5 mg/30 mcg), the generic version of Loestrin Fe 1.5/30, also of Allergan. According to IQVIA, sales data for the 12-month period ending April 2018, the Loestrin 21 1.5/30 tablets market achieved annual sales of approximately $24.2-mn and the Loestrin Fe 1.5/30 market achieved annual sales of approximately $41.3-mn.
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