Mark B. Kreston

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Mark B. Kreston

• President, Worldwide Consumer Medicines

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The OTC Proposition

• Intended dose Pravachol 10 mg once daily
• Use Cholesterol lowering with diet and exercise
• TC 200 - 240 mg/dl
• LDL-C gt 130 mg/dl
• Defined population
• Men gt 35 years and women gt 45 years
• Told by physician to lower cholesterol
• Not on Rx therapy
• No CHD or DM
• Likely to reach NCEP goal
• Maintain physician involvement

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Joint Meeting of Bristol-Myers Squibb and
theNon Prescription Drugs and Endocrinologic and
Metabolic Drugs Advisory CommitteesJuly 14,
2000Pravastatin 10 mg for OTC Status
Agenda

• I. OTC Rationale J. Cohen, MD, FACC, FACP
• II. Pravachol Safety R. Belder, MD
• III. OTC Clinical Program C. Friedman, MD, FACC
• IV. Education and Marketing Programs P. Kriger
• V. Summary C. Friedman, MD, FACC

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Consultants
Michael Bottorff, PharmD University of
Cincinnati Robert L. Brent, MD, PhD, DSc
(Hon) Thomas Jefferson University andAlfred I.
DuPont Hospital for Children W. Virgil Brown,
MD Emory University School of MedicineAtlanta
Department of Veterans Affairs Medical Center J.
Jaime Caro, MDCM, FRCPC, FACP Caro
Research Charles Hennekens, MD University of
Miami School of Medicine Gary G. Koch,
PhD University of North Carolina James H. Lewis,
MD, FACP, FACG Georgetown University Medical
Center Marc Pfeffer, MD, PhD Brigham Womens
Hospital Cardiovascular Division Lorie Rice,
MPH University of California at San
Francisco Dimitrios Trichopoulos, MD Harvard
School of Public Health C. Michael White,
PharmD University of Connecticut