Glenmark gets USFDA approval for Fluocinolone Acetonide Topical Oil

Mumbai: Glenmark Pharmaceuticals Inc. has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for 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.

Fluocinolone topical is a steroid. It reduces the actions of chemicals in the body that cause inflammation. It is body oil is used to treat atopic dermatitis. Fluocinolone scalp oil is used to treat scalp psoriasis.

According to IQVIATM sales data for the 12 month period ending August 2018, the Derma-Smoothe/FS Topical Oil, 0.01% market2 achieved annual sales of approximately $14.5 million*. Glenmark’s current portfolio consists of 140 products authorized for distribution in the U.S. marketplace and 60 ANDAs 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.