TORONTO--(BUSINESS WIRE)--Aug. 24, 2006--Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that it has filed suit against the U.S. Food and Drug Administration (FDA) in the United States District Court for the District of Columbia. Biovail’s legal action refers to its Citizen Petition filed with the FDA on December 20, 2005. That Citizen Petition sets forth Biovail’s position with respect to proper criteria to be employed by the FDA when determining bioequivalence for extended-release generic versions of bupropion products, and particularly those that reference Wellbutrin XL(R). The Citizen Petition also addresses the requirement that the labeling for a bioequivalent product be substantially identical to that of the approved branded product.
