Glenmark Pharma Gets ANDA Nod for Fluocinolone Acetonide Topical Oil | CORPORATE ETHOS

Glenmark Pharma Gets ANDA Nod for Fluocinolone Acetonide Topical Oil

By: | October 26, 2018
glenmark

Oct 26: Glenmark Pharmaceuticals Inc., USA, the US division of Mumbai-based drug maker Glenmark Pharmaceuticals Ltd, on Friday said that it has been granted final approval by the United States Food & Drug Administration (USFDA) for its Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil), a generic version of Derma-Smoothe/FS Topical Oil, 0.01% (Body Oil), of Hill Dermaceuticals, Inc.

According to IQVIATM sales data for the 12 month period ending August 2018, the DermaSmoothe/FS Topical Oil, 0.01% market achieved annual sales of approximately $14.5 million.

Glenmark’s current portfolio consists of 140 products authorized for distribution in the US marketplace and 60 ANDAs pending approval with the USFDA.