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

Glenmark Pharma Gets Final ANDA Nod for Fluocinolone Acetonide Topical Oil

By: | October 30, 2018
Glenmark

Oct 30: Glenmark Pharmaceuticals Inc., USA, the US division of Mumbai-based drug maker Glenmark Pharmaceuticals Ltd, on Tuesday said that it has been granted final approval by the United States Food & Drug Administration (USFDA) for its 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.

Last week, the company had received final approval by the USFDA for its Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil).

According to IQVIATM sales data for the 12 month period ending September 2018, the DermaSmoothe/FS Topical Oil, 0.01% (Scalp Oil) market achieved annual sales of approximately $14 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.