Biovail files abbreviated new drug application for Fenofibrate tablets

Sep 3 2008

Biovail Corporation today announced that the United States Food and Drug Administration (FDA) has accepted the Company's abbreviated new drug application (ANDA) 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 Officer Bill Wells. "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 U.S. revenues of approximately $1.45 billion in the twelve-month period ended June 30, 2008, with the 48mg strength accounting for $69.5 million of the total.