Food and Drug Administration
March 4, 2003
Briefing Information
Factive (Gemifloxacin)
Factive (Gemifloxacin) for the Treatment of Acute Exacerbations of Chronic Bronchitis and Community-Acquired Pneumonia, LG Life Sciences, Ltd., Parexel Int'l., GenSoft Pharm. (PDF)
Factive (Gemifloxacin Mesylate) Tablets, Proposed Indication: Treatment of Community Acquired Pneumonia and Acute Bacterial Exacerbation of Chronic Bronchitis, FDA Review (PDF) (Word)
Errata (PDF)