Biovail Corporation (NYSE:BVF)(TSX:BVF) marketing partner GlaxoSmithKline (GSK) today announced that Wellbutrin XR(R)(1) (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(2) under the Decentralized Procedure.
It is expected that regulatory agencies in various European countries will grant national licenses for Wellbutrin XR(R) throughout the first quarter of 2007, and that the medicine could begin to be available to patients from April 2007.
Wellbutrin XR(R) 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.
Footnotes
(1)According to GSK, Wellbutrin XR(R) will be the most common trade name in European countries. Other trade names include: Elontril (several countries), Voxra (Sweden) and Wellbutrin Retard (Norway).
(2)Austria, Belgium, Cyprus, Czech Republic, Estonia, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, and Sweden.
"Safe Harbor" Statement Under the Private Securities Litigation Reform Act of 1995
To the extent any statements made in this press release contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and within the meaning of the "safe harbor" provisions of applicable Canadian securities legislation. These forward-looking statements relate to, among other things, our objectives, goals, strategies, intentions, plans estimates and outlook, and can generally be identified by the use of words such as "believe", "anticipate", "expect", "intend", "plan", "will", "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements.
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I was set on trying Wellbutrin. I have tried Paxil and one other I can't even recall the name of. They made me feel like a zombie and my husband wasn't fond of them due to the sexual side effects. Wellbutrin was the hardest drug to get accustomed to. I went for a month having one side effect after the other. One week would be sleepless nights, the next would be general irritation at everything and everyone and perhaps the worst was nausea. I stuck it out and I am extremely glad I did. It has been amazing for me. I am much more motivated and excited about life. It increased my sex drive 100%! I also tend to be a social smoker and it obliterated that for me. I love this medicine. I take 400 mg daily.