TORONTO, November 20 /CNW/ - Biovail Corporation (NYSE: BVF)(TSX:BVF)
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
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
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
For further information, please contact Nelson F. Isabel at 905-286-3000
or send inquiries to email@example.com.
For further information:
For further information: Biovail Corporation Nelson F. Isabel,
905-286-3000 Vice-President, Investor Relations and Corporate Communications