Glenmark Pharmaceuticals Receives ANDA Approval for Estradiol Vaginal Inserts

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (US FDA) for 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 USD 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 US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. – Medical Buyer Bureau