Russell
G. Katz, M.D.
July
3, 2003
Page 6
A search of GSK’s internal published literature database [blacked out] was conducted which covers GSK’s major marketed products, devices and compounds in full development. It is sourced from [blacked out] and abstracts from the conference literature not covered by these commercial databases. The search was conducted against title, abstract and controlled vocabulary terms of the world’s literature.
The search was conducted by an Information Scientist in GSK’s Information Management department. The Scientist has a BSPH and MSLS from University of North Carolina and has worked with GSK’s [blacked out]e since 1996. The search strategy used included:
· GSK Drug – bupropion
· Title, abstract, indexing terms – XL or extended release or extended-release or once daily dosing
There were no publications relating to Wellbutrin XL identified from this search.
Additional Pertinent Information
Also, GSK has recently obtained data from a comparative bioavailability study of bupropion 300mg extended release tablets versus bupropion sustained release tablets 150mg in healthy normal volunteers. This pharmacokinetic study was conducted by Biovail Technologies Ltd. of Chantilly, VA, with whom GSK is collaborating in the development of the extended-release formulation of bupropion. The results of the study demonstrate the bioequivalence of once daily bupropion 300mg extended release tablets and twice-daily bupropion sustained-release tablets 150mg under steady-state fasting conditions. A final study report is currently being written and these results will be the subject of a future labeling supplement to Wellbutrin XL.
Labeling (Package Insert and Container Labeling)
1.
In addition to responding to the points listed above,
it will be necessary for you to submit draft labeling revised as shown in the
attachment to this letter.
Item 2 contains the revised product labeling.
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