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Center for Drug Evaluation and Research (CDER)

Anti-Infective Drugs Advisory Committee

September 12, 2006


The committee discussed Factive (gemifloxacin mesylate) Supplemental New Drug Application 21-158/S-006, submitted by Oscient Pharmaceuticals Corporation for the proposed 5-day treatment of acute bacterial sinusitis.

Opening Remarks, Introduction and background to Factive, Renata Albrecht, M.D, Director Division of Special Pathogen and Transplant Products (DSPTP), FDA (ppt) (htm)

Sponsor Presentation

Introduction, Gary Patou, M.D, Director, Oscient Pharmaceuticals Corporation (pdf)

Appropriate Use of Antibiotics in ABS: A Strategy to Minimize Resistance in streptococcus pneumoniae, Donald E. Low, M.D., Professor, Microbiology and Medicine, University of Toronto (pdf)


Gemifloxacin Efficacy Review, Brrylin J. Ferguson, M.D., Director, Division of Sino Nasal Disorders and Allergy, University of Pittsburgh (pdf)

Gemifloxacin Cutaneous Manifistations, Neil Shear, M.D., Professor and Chief of Dermatology, Director, Drug Safety Research, University of Toronto (pdf)

Gemifloxacin Safety Review, Paul Waymack, M.D., Sc.D., President, Waymack Inc. (pdf)

Benefit/Risk & Conclusion, Gary Patou, M.D., Director, Oscient Pharmaceuticals (pdf)

Supplemental [Back-up Slides], Oscient Pharmaeuticals Corporation (pdf)

FDA Presentation

Review of drug development for acute bacterial sinusitis, John Powers, M.D., Medical Officer Team Leader, Office of Antimicrobial Products (OAP) FDA (ppt) (htm)

Medical Officer Review of pre-marketing safety and efficacy of Factive (gemifloxacin) for acute bacterial sinusitis, Maureen Tierney, M.D., Medical Officer, DSPTP, FDA (ppt) (htm)

Review of post marketing safety of Factive (gemifloxacin), Andrew Mosholder, M.D., M.P.H. Medical Officer, Division of Drug Risk Evaluation, Office of Surveillance and Epidemiology, FDA (ppt) (htm)

Questions (ppt) (htm)

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