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Glenmark receives USFDA’s final approval for Fluocinolone Acetonide Topical Oil

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil), a generic version of Derma-Smoothe/FS Topical Oil, 0.01% (Scalp Oil), of Hill Dermaceuticals, Inc.

According to IQVIA sales data for the 12 month period ending September 2018, the DermaSmoothe/FS Topical Oil, 0.01% (Scalp Oil) market achieved annual sales of around $14.0 million.

Glenmark’s current portfolio consists of 141 products authorized for distribution in the US marketplace and 58 ANDA’s pending approval with the USFDA. 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.

Glenmark Pharmaceuticals is a global pharmaceutical company. The company is engaged in the development of new chemical entities (NCEs) and new biological entities (NBEs). Its segments are India, United States, Latin America, Europe and Rest of the World (ROW).