Food and Drug Administration

Anti-Infective Drugs Advisory Committee

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)