September 2005

Biovail's Tramadol ER receives US FDA approval

Biovail Corporation (NYSE,TSE:BVF) 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 will have 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, stated a release here.

Biovail is involved in negotiations related to the commercialization of Tramadol ER by a strategic marketing partner. Tramadol ER will arrive early in 2006.

Dr. Douglas Squires, Biovail's CEO said, "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."

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