Glenmark Pharma gets USFDA nod for Fluocinolone Acetonide Oil

New Delhi: Glenmark Pharmaceuticals on Tuesday said it has received final approval from the US health regulator for Fluocinolone Acetonide Oil, used to treat eczema of the ear.

Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Fluocinolone Acetonide Oil, 0.01 per cent (ear drops), a generic version of DermOtic Oil, 0.01 per cent of Hill Dermaceuticals, Inc," the company said in a BSE filing.

Quoting IQVIA sales data for the 12 month period ending October 2018, Glenmark said, the DermaOtic Oil, 0.01 per cent market achieved annual sales of approximately USD 18.1 million.

The company's current portfolio consists of 146 products authorised for distribution at the US marketplace and 54 abbreviated new drug applications (ANDAs) pending approval with the USFDA.

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