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FDA Issues Approvable Letter for Orally Disintegrating Analgesic

TORONTO, Jan 12, 2005 (BUSINESS WIRE) -- Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced that it has received an Approvable Letter from the United States Food & Drug Administration (FDA) for the New Drug Application (NDA) for its orally disintegrating tablet (ODT) version of the analgesic medication tramadol hydrochloride, intended for the treatment of moderate to moderately severe pain.

Biovail's NDA for this formulation was accepted for review by the FDA in May 2004. The Approvable Letter involves the resolution of labeling issues only, including, but not limited to, resolution of a final trademarked name for the product. Biovail anticipates resolving these issues with the FDA shortly.

Subject to final FDA approval, Biovail's orally disintegrating tablet version of immediate-release tramadol hydrochloride will be available in 50mg tablets by prescription only. Patients will benefit from the convenience of this formulation manufactured with Biovail's FlashDose(R) technology -- particularly those who have difficulty swallowing tablets, or those who may not, or do not, always have access to water. A study of the American population concluded that nearly 40% of adults have experienced problems with swallowing tablets -- and a significant proportion of those fail to comply properly with their prescribed and ongoing dosage. Conditions such as post-procedural pain with swelling, associated with swallowing impairment, that require acute analgesic treatment, will benefit from the immediate orally dissolving tablet form.

Biovail is considering a number of commercialization alternatives and an appropriate trade name for the product at the present time. Biovail anticipates submitting a full response to the FDA's Approvable Letter in the coming weeks.

About Tramadol
Tramadol is a centrally acting synthetic opioid analgesic, effective in the treatment of pain. Tramadol's minimal propensity to induce adverse effects is an advantage over morphine-like agents. Relative to morphine, tramadol causes less dependence and less respiratory depression.

Tramadol is currently available under the brand name Ultram(R) (a product of Ortho-McNeil, a division of Johnson and Johnson), and in several generic formulations. Branded and generic formulations of tramadol are indicated for the management of moderate to moderately severe pain, and may be dosed four to six times per day.

Source: Biovail Corporation

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