New Delhi: Glenmark Pharmaceuticals Friday said its US arm has received final nod from the US health regulator for generic Fluocinolone Acetonide Topical oil used for treatment of inflammation of skin. Glenmark Pharmaceuticals Inc has been granted final approval by the United States Food & Drug Administration (USFDA) for the oil in the strength of 0.01 per cent, the Mumbai-based company said in a statement.
The product is a generic version of Hill Dermaceuticals Inc’s Derma-Smoothe/FS Topical oil in the same strength, it added.
The body oil is indicated for the topical treatment of atopic dermatitis in adult patients.
“According to IQVIA sales data for the 12 months ended August 2018, the Derma-Smoothe/FS Topical oil, 0.01 per cent market (including brand and available therapeutic equivalents) achieved annual sales of approximately USD 14.5 million,” Glenmark Pharma said.
The company’s current portfolio consists of 140 products authorised for distribution in the US and 60 abbreviated new drug applications (ANDAs) pending approval with the USFDA, it added.
Shares of Glenmark Pharma were trading at Rs 592.25 per scrip on BSE, down 3.33 per cent from the previous close.