Glenmark receives ANDA approval for steroidal drug from US FDA
Glenmark Pharmaceuticals Inc., USA has been granted final approval by the US FDA for Estradiol Vaginal Inserts USP, 10 mcg, the generic version of Vagifem1, 10 mcg, of Novo Nordisk Inc.
According to IQVIA sales data for the 12-month period ending July 2018, the Novo Nordisk product achieved annual sales of approximately $286.3-mn.
Glenmark’s current portfolio consists of 139 products authorized for distribution in the US market 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.
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