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In Brief: Glaxo Wellcome's Zyban

This article was originally published in The Tan Sheet

Executive Summary

Glaxo Wellcome's Zyban: Prescription sustained-release bupropion HCl smoking cessation therapy set for July launch after clearing FDA on May 14. Glaxo's NDA (20-711) was submitted May 17, 1996. The firm already markets bupropion as Wellbutrin SR for depression. Zyban labeling recommends a seven-week trial period for response to the drug with normal treatment duration of up to 12 weeks, although longer therapy may be considered. Glaxo will be the first company trying to build a long-term Rx-only business for smoking cessation; risk of seizures associated with bupropion likely rules the agent out as an OTC switch candidate. Nicotrol nasal spray and oral inhaler nicotine replacement forms, marketed by McNeil, are considered near-term switch candidates, although issues of abuse potentially could complicate the process...
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