Glenmark Pharmaceuticals receives ANDA approval for Fluocinolone Acetonide Oil

Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio

Glenmark Pharmaceuticals, USA (Glenmark) has been granted final approval by the United States Food and Drug Administration (US FDA) for Fluocinolone Acetonide Oil, 0.01 per cent (ear drops), a generic version of DermOtic Oil, 0.01 per cent (ear drops), of Hill Dermaceuticals. According to IQVIATM sales data for the 12 month period ending October 2018, the DermaOtic Oil, 0.01 per cent (ear drops) market achieved annual sales of approximately $18.1 million. Glenmark’s current portfolio consists of 146 products authorised for distribution in the US marketplace and 54 ANDA’s pending approval with the US 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.