Sold as Factive. Every FDA application for this active ingredient: 1 branded and 1 generic.
As of Nov 15, 2026, FDA lists 2 applications for Gemifloxacin Mesylate (sold as Factive), first approved Apr 4, 2003, with 2 new uses approved and 0 published complete response letters.
| Study | Phase | Status | Posted |
|---|---|---|---|
| Oral Gemifloxacin Versus Intravenous Cefotaxime in Treatment of Spontaneous Bacterial PeritonitisSpontaneous Bacterial Peritonitis · Tanta University | Phase 3 | Recruiting | Nov 19, 2019 |
| Apr 4, 2003 | FactiveNDA 21158 · New molecular entity | Lg Chem Ltd | 17 | Discontinued |
| Jun 15, 2015 | Gemifloxacin MesylateANDA 90466 | Orbion Pharms | 4 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
