Published in AIDS Weekly, June 24th, 1996
The committee voted 7-2 against recommendation for FDA approval, citing concerns over risks versus benefits associated with use of the antiviral agent. The committee reviewed data from Japan, where sorivudine is marketed, that showed that 26 cancer patients given sorivudine for herpes zoster while on 5-fluorouracil developed severe toxicities and that 18 of the 26 patients had died.
Bristol-Myers representatives requested orphan drug status for...
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