Biovail Confirms FDA Class 2 Status For BVF-033 Submission
TORONTO--(BUSINESS WIRE)--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.
Posted: November 2007
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