The Hindu Business Line : USFDA tentative nod for Ranbaxy's cholesterol drug

RANBAXY Laboratories Ltd has received tentative approval from the US Food and Drug Administration (USFDA), Office of Generic Drugs, to manufacture and market Fenofibrate tablets — a cardiovascular medication, used for the treatment of hypercholesterolemia.

The company has received a nod for its 54 mg, 107 mg, 160 mg tablets. While the total market for Fenofibrate tablets was $675 million, the total market sales for Abbott Laboratories' brand, Tricor, which has a monopoly in the segment, stood at $669 million.

Fenofibrate tablets are indicated for the treatment of cardiovascular ailments and also helps reduce cholesterol. It is also recommended to patients suffering from diabetes.

In a statement, Mr Jim Meehan, Vice-President, Sales and Marketing, RPI, USA, said, "Subject to receiving final FDA approval, we will introduce Fenofibrate tablets to further expand our product portfolio of affordable generic alternatives. This product offering, in the cardiovascular class of medications, will provide benefits to the US healthcare system, prescribers and patients."

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