Glenmark gets USFDA nod for generic of Loestrin tablets to prevent pregnancy
"Glenmark Pharmaceuticals USA has been granted final approval by the US Food and Drug Administration (USFDA) for Hailey 24 Fe (Norethindrone Acetate and Ethinyl Estradiol tablets, USP and Ferrous Fumarate tablets), 1 mg/20 mcg, the generic version of Loestrin 1 24 Fe tablets, of Allergan Pharmaceuticals," the company said in a BSE filing today.
New Delhi: 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 24 Fe (Norethindrone Acetate and Ethinyl Estradiol tablets, USP and Ferrous Fumarate tablets), 1 mg/20 mcg, the generic version of Loestrin 1 24 Fe tablets, of Allergan Pharmaceuticals," the company said in a BSE filing today.
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According to IQVIATM sales data for the 12 months to September 2017, the Loestrin 24 Fe tablets market achieved annual sales of approximately USD 96.7 million, Glenmark said.
The company's current portfolio consists of 128 products authorised for distribution at the US marketplace and 59 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA.
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Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here
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