Mumbai, Sep 17 (UNI) Pharma MajorGlenmark Pharma said that Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food and Drug Administration (USFDA) for Estradiol
Vaginal Inserts USP, 10 mcg.
The approved product is a generic version of Novo Nordisk Inc's VAGIFEM, Glenmark said in a filing with BSE.
According to 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.
UNI JS JA 1228