Endocrinologic and Metabolic Drugs Advisory
Committee
Holiday Inn
Slides
The committee will discuss new drug application (NDA)
21-865, proposed trade name Pargluva (muraglitazar) Tablets, 2.5 milligrams
(mg) and 5 mg, Bristol-Myers Squibb, for the treatment of type II diabetes
mellitus.
Sponsor Presentation: [HTML] [PPT]
Introduction Brian
Daniels, M.D.
Senior
Vice President
Global
Clinical Development
Bristol-Myers
Squibb Company
Meeting the Needs for Type 2 DM David M. Kendall M.D.
Muraglitazar Overview Fred
Fiedorek M.D.
Vice
President
Global
Clinical Research
Bristol-Myers
Squibb Company
Non-Clinical Safety Mark
Dominick D.V.M., Ph.D.
Distinguished
Research Fellow
Drug
Safety Evaluation
Clinical Efficacy Cindy
Rubin M.D.
Group
Director
Global
Clinical Research
Bristol-Myers
Squibb Company
Clinical Safety Rene
Belder M.D .
Vice
President
Global
Clinical Research
Bristol-Myers
Squibb Company
Clinical Plans, Pharmacovigilance Fred Fiedorek M.D.
and Benefit/Risk Conclusions
Backup Slides Presented [HTML] [PPT]
FDA Review Division Presentation:
Clinical Review Julie Golden, M.D.
Medical
Officer
Division
of Metabolic and Endocrine Drug Products
Pharmacology/Toxicology Jeri El Hage, Ph.D.
Review Pharmacologist
Division
of Metabolic and Endocrine Drug Products