CENTER FOR
DRUG EVALUATION AND RESEARCH (CDER)
Anti-Infective Drugs Advisory
Committee
CDER Advisory Committee
Conference Room, Room 1066
SLIDES PRESENTED DURING
MEETING
The
committee will discuss new drug application (NDA) 21-572/S-008, Cubicin
(daptomycin for injection 500 mg/vial); Sponsor Cubist Pharmaceuticals, for the
proposed indication of the treatment of Staphylococcus aureus bacteremia,
including those with known or suspected endocarditis caused by
methicillin-susceptible and methicillin-resistant strains.
PPT Introduction Janice Soreth, M.D.
Director
Division
of Anti-Infective and Ophthalmology Products
CDER, FDA
Food and Drug
Administration Guest Speaker Presentation
PPT S. aureus Bacteremia and John
Edwards, Jr., M.D.
Endocarditis:
Epidemiologic Professor of
Medicine,
Chief,
Infectious Diseases, Department of Medicine
Harbor-
Cubist
Pharmaceuticals Presentation
PPT Overview of S.
aureus Disease Henry Chambers, M.D.
Professor of Medicine
Chief,
Division of Infectious Diseases,
PPT Introduction David
Mantus, Ph.D.
Vice President, Regulatory
Affairs
Cubist
Pharmaceuticals
PPT Efficacy Results Helen
Whamond Boucher, M.D.
Assistant Professor of Medicine
Division
of Infectious Diseases and Geographic Medicine
PPT Microbiology Jeff
Alder, Ph.D.
Vice President, Drug Discovery
and Evaluation
Cubist
Pharmaceuticals
PPT Safety
Results Gloria
Vigliani, M.D.
Vice President, Medical Strategy
Cubist
Pharmaceuticals
PPT Overview of Benefits/Risks G.
Ralph Corey, M.D.
Professor of Internal
Medicine & Infectious Disease
PPT Supplemental [Back-up Slides] Cubist Pharmaceuticals
Food and Drug
Administration Presentation
PPT Efficacy
Results Alfred
Sorbello, D.O.
Medical Officer
Division
of Anti-Infective and Ophthalmology Products
CDER, FDA
PPT Microbiology Peter Coderre, Ph.D.,
M.B.A.
Microbiologist
Division
of Anti-Infective and Ophthalmology Products
CDER, FDA
PPT Safety Results Charles Cooper, M.D.
Medical Officer
Division of
Anti-Infective and Ophthalmology Products
CDER, FDA
PPT Questions to the Committee