Canada's Biovail files ANDA for fenofibrate

Toronto, Canada-based Biovail says that the US Food and Drug Administration has accepted its Abbreviated New Drug Application for a generic formulation of 145mg and 48mg strengths of fenofibrate tablets (sold under the brand name Tricor by Abbott Laboratories).

"This represents the second successful ANDA filing in the past six months," said Biovail chief executive Bill Wells, adding: "while our primary focus remains the implementation of our new strategic focus, we continue to make progress with our existing pipeline products."

Tricor is a lipid-lowering agent used to treat abnormal lipid levels in the bloodstream, including cholesterol and triglycerides. The product is available in 145mg and 48mg strengths. According to IMS Health, Tricor generated US revenues of around $1.45 billion in the 12-month period ended June 30, with the 48mg strength accounting for $69.5 million of the total.