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The USFDA has provided its final approval to Aurobindo Pharma for manufacturing and marketing Fenofibrate tablets that are used in the treatment of high level of cholesterol, in the American market.
Aurobindo Pharma has said in a BSE filing that “The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fenofibrate Tablets, 48 mg and 145 mg.”
The product is likely to be launched in the first quarter of this fiscal.
It added that the approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Tricor tablets of AbbVie Inc.
