Biovail Corporation marketing partner GlaxoSmithKline (GSK) today announced that Wellbutrin XR (bupropion hydrochloride modified-release tablets), has been granted a marketing license in The Netherlands for the treatment of adult patients with major depressive episodes. The medicine is also considered approvable by the regulatory agencies of 21 other countries under the Decentralized Procedure.
It is expected that regulatory agencies in various European countries will grant national licenses for Wellbutrin XRthroughout the first quarter of 2007, and that the medicine could begin to be available to patients from April 2007.
Wellbutrin XR is available as a 150mg or 300mg tablet, with a dose of up to 300mg once daily, starting with 150mg once daily.
Pursuant to the agreement signed in 2001 between Biovail and GSK, Biovail will manufacture and supply the product to GSK at a fixed, contractually determined price.
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