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Glenmark Pharma receives ANDA approval for Fluocinolone Acetonide Oil

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Fluocinolone Acetonide Oil, 0.01% (Ear Drops), a generic version of DermOtic 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) market achieved annual sales of approximately $18.1 million.

The company’s current portfolio consists of 146 products authorized for distribution in the US marketplace and 54 ANDA’s pending approval with the USFDA. In addition to these internal filings, the company continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

Glenmark Pharmaceuticals is a global pharmaceutical company. The company is engaged in the development of new chemical entities (NCEs) and new biological entities (NBEs). Its segments are India, United States, Latin America, Europe and Rest of the World (ROW).

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