Ranbaxy Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration, Office of Generic Drugs, to manufacture and market fenofibrate tablets, 54 mg, 107 mg, 160 mg. Total market sales for Tricor (fenofibrate tablets) were $669 million in a total fenofibrate market of $675 million (+38 per cent) (IMS - MAT: March 2004), a company release said.

Fenofibrate tablets is indicated for the treatment of hypercholesterolemia. Tricor is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Frederickson Types IIa and IIb).

Fenofibrate tablets is also indicated for the treatment of hypertriglyceridemia. Tricor is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Frederickson Types IV and V hyperlipidemia). Improving glycemic control in diabetes patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention.

Commenting on the occasion, 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".