TORONTO--(BUSINESS WIRE)--Biovail Corporation (NYSE:BVF - News; TSX:BVF - News) today announced that it has received a Non-Approval letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for BVF-033, a novel once-daily salt formulation of bupropion. The main issue raised by the FDA in its letter related to the design of the pharmacokinetic studies required to support the NDA. Biovail believes the studies were appropriate. However, the Company is evaluating the issue and will meet with the FDA as soon as possible to discuss necessary steps to resolve this matter.
To the extent any statements made in this press release contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and within the meaning of the "safe harbor" provisions of applicable Canadian securities legislation. These forward-looking statements relate to, among other things, our intentions and plans and can generally be identified by the use of words such as "believes" and "will" and other similar expressions. Although Biovail believes that the expectations and intentions reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Specifically the risks and uncertainties the Company faces include, but are not limited to, the uncertainties related to the regulatory process, including regulatory approval. Additional information about these factors may be found in the body of this news release, and under the heading "Risk Factors" contained in Item 3(D) of Biovail's most recent Annual Report on Form 20-F/A.
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.
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Source: Biovail Corporation