Glenmark Pharma gets USFDA approval for generic version of VAGIFEM
The approved product Estradiol Vaginal Inserts USP, 10 mcg is a generic version of Novo Nordisk Inc's VAGIFEM.
New Delhi: Glenmark Pharmaceuticals has received final approval from the US health regulator for generic version of Nordisk Inc's VAGIFEM, used for providing relief from menopause symptom.
"Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food and DrugAdministration (USFDA) 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 Inc'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 USD 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.