SmithKline Beecham’s Kytril (granisetron)
Will be reviewed by FDA's Gastrointestinal Drugs Advisory Committee on March 11. The NDA for the 5HT antagonist was filed in December 1991. SmithKline Beecham is seeking approval of Kytril for use in preventing "nausea and vomiting associated with initial and repeated courses of emetogenic cancer therapy, including high-dose cisplatin" -- the same indication received by Glaxo's 5HT antagonist Zofran (ondansetron) when it was approved in January 1991. On March 12, the advisory committee is scheduled to discuss H receptor-antagonists and gastric alcohol dehydrogenase.
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