BIOVAIL'S WELLBUTRIN APPROVED IN THE NETHERLANDS

Biovail announced that its marketing partner GlaxoSmithKline (GSK) has been granted approval to market Wellbutrin XR (bupropion hydrochloride modified-release tablets) for treating adult patients with major depressive episodes in the Netherlands. The drug is also considered approvable by the regulatory agencies of 21 other European countries under the European Commission's decentralized procedure.

The company expects that regulatory agencies in the various European countries will grant licenses to market Wellbutrin XR throughout the first quarter, and that the drug could become available to patients beginning in April.

Wellbutrin XR is available as a 150- or 300-mg tablet and indicated for once-daily dosing. Pursuant to the agreement signed in 2001, Biovail will manufacture and supply the product to GSK at a fixed price.

The drug was previously approved in the U.S. and Canada for treating depression and seasonal affective disorder.