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Glenmark Pharmaceuticals has received final approval from the US health regulator for generic version of Nordisk Inc’s VAGIFEM, which is used for providing relief from menopause symptom.
“Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food and Drug Administration (USFDA) for Estradiol Vaginal Inserts USP, 10 mcg,” the company said in a regulatory filing on Monday.
The approved product is a generic version of Novo Nordisk Inc’s VAGIFEM. Quoting IQVIA sales data for the 12-month period ended July 2018, Glenmark said VAGIFEM, 10 mcg, market achieved annual sales of approximately $286.3 million.
The company’s current portfolio consists of 139 products authorised for distribution at the US marketplace and 61 abbreviated new drug applications (ANDAs) pending approval with the USFDA. Glenmark shares were trading down 0.93 per cent at Rs 684.45 on the BSE.
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