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Glenmark receives US FDA nod for cholesterol-lowering drug fenofibrate

The approved product - fenofibrate capsule - is a generic version of AbbVie's Tricor capsule

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Last Updated : Apr 11 2017 | 5:16 PM IST

Glenmark Pharmaceuticals has been granted final approval by the US Food & Drug Administration (FDA) for Fenofibrate capsule (67 mg, 134 mg and 200 mg). Fenofibrate, a drug of the fibrate class, is mainly used to reduce cholesterol levels in people at risk of cardiovascular disease.

The approved product is the generic version of AbbVie Inc’s Tricor micronised capsule.

According to IMS Health sales data for the 12 month period ending February 2017, the Tricor micronised capsule (67 mg, 134 mg and 200 mg) market achieved annual sales of approximately $ 97.5 million.

Glenmark’s current portfolio consists of 114 products authorised for distribution in the US marketplace and approximately 64 ANDAs are 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.