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Biovail's Tramadol ER Receives FDA Approval

TORONTO, September 9, 2005 - Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that its New Drug Application (NDA) for a once-daily formulation of tramadol hydrochloride (Tramadol ER) has received final approval from the United States Food and Drug Administration (FDA).

Tramadol ER has been approved for the treatment of moderate to moderately severe chronic pain in once-daily 100mg, 200mg and 300mg dosage strengths. Biovail is the first and only company to submit an application to the FDA for review, and to receive an approval for a once-daily tramadol formulation.

Biovail is actively involved in negotiations related to the commercialization of Tramadol ER by a strategic marketing partner. The Company expects to conclude these negotiations soon, and anticipates the commercial launch of Tramadol ER to occur in early 2006.

As a trade name is currently being finalized for the product, the label, as approved by the FDA, refers to the product as "Tradename ER".

"This is an important milestone as it further demonstrates Biovail’s technological and scientific capability in utilizing advanced drug-delivery technologies to add significant clinical benefits to medications," said Dr. Douglas Squires, Biovail’s Chief Executive Officer. "The timing of the approval gives Biovail a significant competitive advantage, and allows us to further diversify our revenue base. The conditions of approval by the FDA for Tramadol ER support three years of exclusivity for the indication and doses approved."

Source: Biovail Corporation

Posted: September 2005