Glenmark receives ANDA approval for Fluocinolone Acetonide Oil, 0.01% (Ear Drops)

Glenmark Pharmaceuticals Inc. USA 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 DermOtic1 Oil, 0.01% (Ear Drops), of Hill Dermaceuticals, Inc.

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

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