Biovail Confirms FDA Class 2 Status For BVF-033 Submission
TORONTO -- Nov. 20, 2007--Biovail Corporation today confirmed that the U.S. Food and Drug Administration (FDA) has classified the response submitted by the Company October 23, 2007, to the FDA Action Letter for BVF-033, its novel salt formulation of bupropion, as Class 2.
A Class 2 response is subject to a six-month review period by the FDA. A PDUFA date of April 23, 2008, has been set for receipt of the FDA's decision.
"Biovail is surprised and disappointed by the FDA's decision with respect to the status of our Complete Response," said Biovail Chief Executive Office Dr. Douglas Squires. "Biovail remains fully committed to securing the approval of BVF-033."
Biovail continues to believe the data package submitted to the FDA is sufficient to support the approval of BVF-033.
"Safe Harbor" Statement Under the Private Securities Litigation Reform Act of 1995
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.