Center
for Drug Evaluation and Research (CDER)
Anti-Infective
Drugs Advisory Committee
September 12, 2006
Slides
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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