Glenmark Pharma receives USFDA approval for Estradiol Vaginal Insert

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

New Delhi: Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Estradiol Vaginal.

Inserts USP, 10 mcg, the generic version of VAGIFEM®1, 10 mcg, of Novo Nordisk Inc.
According to IQVIATM sales data for the 12 month period ending July 2018, the VAGIFEM®, 10 mcg
market2 achieved annual sales of approximately $286.3 million. As of filing to BSE

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