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Glenmark Pharmaceuticals has received final approval from the US health regulator for a generic version of Loestrin tablets used to prevent pregnancy.
“Glenmark Pharmaceuticals USA has been granted final approval by the US Food and 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 1/20 Fe tablets, of Allergan Pharmaceuticals,” the company said in a BSE filing today.
For the 12 months to September 2017, Loestrin Fe 1/20 tablets market achieved annual sales of approximately $116.8 million, Glenmark said, citing IQVIATM sales data.
The company’s current portfolio consists of 129 products authorised for distribution at the US marketplace and 58 abbreviated new drug applications (ANDA) pending approval with the USFDA.
Glenmark shares ended lower by 0.34 per cent at Rs 590.40 on the BSE.
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