GW files for EU approval of Zyban

Glaxo Wellcome has applied to the regulatory authorities for approval tomarket its non-nicotine prescription tablet for smoking cessation Zyban (bupropion hydro-chloride) in the European Union.

The drug has been available in the USA since 1997 where, the company claims, it has enabled over one million people to stop smoking, clocking up first-year sales of L96 million ($154.4 million) along the way. It is also available in Canada after its approval there last year (Marketletter August 24, 1998). It acts through the central nervous system's addiction pathways, decreasing the craving for nicotine and reducing the effects of withdrawal symptoms.

Analysts at Morgan Stanley Dean Witter suggest that the US figures for Zyban may not even reflect the actual total as some of the sales may have been classified as antidepressants as GW's Wellbutrin, which has the same active ingredient and it is "easier to get reimbursement for a CNS claim than a smoking cessation claim."