Glenmark Gets ANDA Nod for Estradiol Vaginal Inserts | CORPORATE ETHOS

Glenmark Gets ANDA Nod for Estradiol Vaginal Inserts

By: | September 17, 2018
glenmark

Sep 17: Glenmark Pharmaceuticals Inc., USA, the US division of Mumbai-based drug maker Glenmark Pharmaceuticals Ltd, on Monday said that it has been granted final approval by the United States Food & Drug Administration (USFDA) for its Estradiol Vaginal Inserts USP, 10 mcg, the generic version of VAGIFEM, 10 mcg, of Novo Nordisk Inc.

According to IQVIATM sales data for the 12 month period ending July 2018, the VAGIFEM, 10 mcg market achieved annual sales of approximately $286.3 million.

Glenmark’s current portfolio consists of 139 products authorized for distribution in the US marketplace and 61 ANDA’s pending approval with the USFDA.