Glenmark Pharma gets final US FDA nod for menopause symptom relief drug

Glenmark Pharmaceuticals has received final approval from the US health regulator for a generic version of Nordisk’s VAGIFEM, used for providing relief from menopause symptom.

"Glenmark Pharmaceuticals, USA has been granted final approval by the United States Food and Drug Administration (US FDA) for Estradiol Vaginal Inserts USP, 10 mcg," the company said in a regulatory filing Monday.

The approved product is a generic version of Novo Nordisk’s VAGIFEM.

Quoting IQVIA sales data for the 12 month period ending July 2018, Glenmark said VAGIFEM, 10 mcg, market achieved annual sales of approximately $286.3 million.

Glenmark’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 US FDA.

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