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Biovail Submits Citizen Petition to FDA

Posted on: Wednesday, 21 December 2005, 15:00 CST

Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today the submission of a Citizen Petition with the Food and Drug Administration (FDA) to require rigorous bioequivalence testing for generic products that reference Wellbutrin XL(R) before they can be approved. Biovail has taken this step to protect patients against potentially serious risks (particularly seizures) which are currently disclosed in the approved Wellbutrin XL(R) labeling, and to ensure that generic versions of Wellbutrin XL(R) are as safe and effective as the innovator product.

In order to assess the potential risks of a generic formulation of bupropion extended-release tablets, Biovail believes it is critical that the FDA require that any Abbreviated New Drug Application (ANDA) for a generic version of Wellbutrin XL(R) satisfy the following criteria:

a. All bioequivalence trials should calculate and evaluate parameters based on concentrations of the parent drug and active metabolites.

b. Any generic formulation should be shown, based on the above criteria, to be bioequivalent to Wellbutrin XL(R), sustained-release, and immediate-release bupropion.

c. The bioequivalence studies described above should be conducted at steady-state evaluating the performance of the dosage form based on a number of metrics, including area under the curve (AUC), maximum concentration (Cmax), and minimum concentration (Cmin).

d. Data using FDA's in vitro approach for evaluating the effect of alcohol on the performance of the controlled-release dosage form should be required to ensure the absence of "dose dumping" if the drug is consumed with alcohol.

The Citizen Petition is expected to be posted on the FDA website shortly, and will be made available on www.biovail.com thereafter.

Beyond the issues raised in the Citizen Petition, Biovail is also assessing other safety and efficacy concerns related to generic formulations of Wellbutrin XL(R).

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.

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 and Canadian Therapeutic Products Directorate 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, tax rate assumptions, availability of raw materials and finished products, the regulatory environment, the outcome of legal proceedings, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission and the Ontario Securities Commission. Biovail undertakes no obligation to update or revise any forward-looking statement.

Source: Business Wire

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