TORONTO — Biovail Corporation (NYSE:BVF) (TSX:BVF) has been advised that GlaxoSmithKline (GSK) has received a Notice of Patent Certification associated with an abbreviated new drug application (ANDA) that has been submitted to the U.S. Food and Drug Administration (FDA) by Abrika Pharmaceuticals LLP of Sunrise, FL, seeking marketing approval for a 150 mg generic formulation of Wellbutrin XL(R) (once-daily bupropion).
On November 17, Biovail announced that it received notification that Anchen Pharmaceuticals, Inc. had filed an ANDA for a generic formulation of Wellbutrin XL(R). Dr. Chih-Ming Chen, Chairman and Chief Executive Officer of Anchen, and Alan Cohen, Chairman and General Partner of Abrika, were co-founders of Andrx Corporation.
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Biovail continues to develop a new once-daily bupropion formulation. Biovail’s goal is to provide further enhancements to its once-daily bupropion formulation (currently marketed by GlaxoSmithKline under the brand name Wellbutrin XL(R)), and is targeting the initiation of relevant studies in the first half of 2005, which could lead to a submission to the FDA by the second half of 2005.
About Biovail Corporation
Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion 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.
“Safe Harbor” Statement Under the Private Securities Litigation Reform Act of 1995
To the extent any statements made in this 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. We have based these forward-looking statements on our current expectations and projections about future events. Our actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by words such as “believe”, “anticipate”, “expect”, “intend”, “plan”, “will”, “may” and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Forward-looking statements include, but are not necessarily limited to, risks and uncertainties, including the difficulty of predicting U.S. Food and Drug Administration (”FDA”) and Canadian Therapeutic Products Directorate (”TPD”) approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials and finished products, third parties, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company’s filings with the Securities and Exchange Commission (”SEC”) and the Ontario Securities Commission (”OSC”). Biovail Corporation undertakes no obligation to update or revise any forward-looking statement.
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