Biovail Commences Legal Action to Enforce Criteria Set Forth in Its Citizen Petition.TORONTO -- Biovail Corporation (NYSE NYSE See: New York Stock Exchange :BVF BVF Biovail Corporation (stock symbol) BVF Berufsverband der Frauenärzte eV (Muenchen, Germany) BVF Bearing Versus Frequency )(TSX:BVF) today announced that it has filed suit against the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) in the United States District Court for the District of Columbia The United States District Court for the District of Columbia is the United States District Court that hears cases originating in the District of Columbia over which federal courts have original jurisdiction. . 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 bupropion /bu·pro·pi·on/ (bu-pro´pe-on) a monocyclic compound structurally similar to amphetamine, used as the hydrochloride salt as an antidepressant and as an aid in smoking cessation. 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. Biovail seeks a Temporary Restraining Order temporary restraining order: see injunction. and a Preliminary Injunction directing the FDA to resolve the issues raised by Biovail's Citizen Petition at least one week prior to the FDA's purported approval of any generic versions of Wellbutrin XL(R) to ensure that Biovail may seek judicial review, if appropriate, of any FDA decision that does not incorporate Biovail's stated approval criteria as set forth in its Citizen Petition. Biovail's Citizen Petition is intended to protect the public against the potentially harmful effects of generic versions of Wellbutrin XL(R) that may not, in fact, be bioequivalent to Biovail's branded product, or that may be misleadingly labeled, under the criteria set forth in the Company's Citizen Petition. The bioequivalence and labeling criteria set forth in Biovail's Citizen Petition, if followed, would help ensure such protection for the public. Biovail's Citizen Petition, Docket No. 2005P-0498, is accessible on the Company's website, at the following URL URL in full Uniform Resource Locator Address of a resource on the Internet. The resource can be any type of file stored on a server, such as a Web page, a text file, a graphics file, or an application program. link: http://www.biovail.com/local/files/Resources/Petition.pdf. About Biovail Corporation Biovail Corporation is a specialty pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture and commercialization of pharmaceutical products utilizing advanced drug-delivery technologies. For more information about Biovail, visit the company's Web site at www.biovail.com. For further information, please contact Ken Howling at 905-286-3000 or send inquiries to ir@biovail.com. |
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