FDA APPROVES BIOVAIL'S GENERIC PROCARDIA XL 30MG DOSAGE.

Biovail Corporation (NYSE:BVF)(TSE:BVF), Toronto, has announced that its 30mg dosage strength of generic Procardia XL (once daily nifedipine) has been granted final approval by the Food and Drug Administration (FDA) for immediate marketing in the United States. Biovail had previously received an approval for its 60mg Procardia XL dosage strength. Procardia XL is indicated for the treatment of hypertension and angina and total brand sales for both strengths was $299.7 million, of which $130 million was for the 30mg dosage strength, for the twelve months ended October 31, 2000. In December, Biovail announced that it had also filed the 90mg generic version of Procardia XL which had brand sales of $85.8 million.

Eugene Melnyk, chairman of the board, commented, "The FDA's approval has been granted despite the anti-competitive agreement between Mylan Pharmaceuticals and Pfizer, Inc. which attempted to preclude final approval and commercialization of Biovail's product. Biovail and its licensee, Teva Pharmaceuticals, collaborated in filing a Citizen's Petition and a lawsuit with the FDA requesting that final approval of Biovail's product be effected immediately."

In granting final approval to Biovail, the FDA stated that to permit Mylan to continue to market Pfizer's licensed 30 mg Procardia XL in these circumstances would deprive the American consumer from the benefits of generic competition and would be contrary to the intention of Congress in enacting the provisions relating to the exclusivity of a first filer under the Waxman-Hatch amendments.

It is expected that 30mg dosage strength of this product will be launched immediately.

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.

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