The quinolone Factive (gemifloxacin mesylate) rose from the ashes March4, when the US Food and Drug Administration's Anti-Infective Drugs Advisory Committee voted to approve the drug.
GlaxoSmithKline submitted the original New Drug Application for Factive in 1999 and received a non-approvable letter in December 2000 (Marketletters passim). The FDA was concerned that GSK was making broad claims not supported by the data, and that Factive might be causing excessive liver enzyme elevations and skin rashes. As a result, GSK abandoned development of the drug.
Korean drug maker LG Life Sciences then rescued Factive and licensed its North American and European rights to privately held GeneSoft Pharmaceuticals. Parexel International assisted with a new study and analysis and re-submitted the NDA in October 2002.
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