Food and Drug Administration

Anti-Infective Drugs Advisory Committee

March 4, 2003


Factive® (gemifloxacin) Tablets


The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Factive (gemifloxacin), Dr. Renata Albrecht, MD, FDA (HTM) (PPT)

Adverse Cutaneous Reactions to Drugs, Dr. Michael Bigby, MD, FDA (HTM) (PPT)Antimicrobial Resistance in Streptococcus Pnewmoniae - Inplications for Prescription Drug Labeling, Dr. John Powers, MD (HTM) (PPT)

Gemifloxacin - A Potent Dual Targeting Fluoroquinolone, Life Science (PDF)

FDA Presentations Regarding Factive® (gemifloxacin), Dr. Edward Cox, MD, MPH (HTM) (PPT)

Charge to the Committee, Dr. Mark Goldberger, MD, MPH, FDA (HTM) (PPT)