Zyban

Zyban (bupropion) received marketing authorization for smoking cessation in all European Union countries, except for France and Finland. The approval, announced in April 2000, was granted via the European Commission's mutual recognition procedure. Zyban was approved in December by authorities in the reference member country, the Netherlands.

Zyban sustained-release tablet is the first nicotine-free prescription medicine approved for marketing for smoking cessation.

According to company data, the product has helped more than 1 million individuals stop smoking. Researchers believe that Zyban acts on the central nervous system's addiction pathways, thereby decreasing the craving for nicotine and reducing withdrawal symptoms.

Zyban was launched in 1997 in the United States by developer and marketer Glaxo Wellcome Inc., Research Triangle Park, N.C.

The product was filed for approval in the European Union in March 1999; additional discussions are planned with regulatory authorities in France and Finland. Reports indicate that 70% of Europeans want to quit smoking. There are more than 200 million smokers in Europe. The World Health Organization estimates that tobacco products are responsible for 1.2 million deaths annually in Europe.

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