Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Fluocinolone Acetonide Oil, 0.01% (Ear Drops), a generic version of DermOtic Oil, 0.01% (Ear Drops), of Hill Dermaceuticals, Inc.

According to IQVIATM sales data for the 12 month period ending October 2018, the DermaOtic Oil, 0.01% (Ear Drops) market2 achieved annual sales of approximately USD 18.1 million.

Glenmark's current portfolio consists of 146 products authorized for distribution in the U.S. marketplace and 54 ANDA's pending approval with the U.S. 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.