Food and Drug Administration

Joint meeting of the Nonprescription Drugs Advisory Committee and Endocrinological and Metabolic Drugs Advisory Committee

July 14, 2000

Slides

Pravachol® NDA 21-198, pravastatin sodium

Clinical Efficacy and Safety Review, Mary H Parks, MD, FDA   ppt

Actual Use Trials, Daiva Shetty, MD,  FDA   ppt

Pravachol 10 Label Comprehension Study, Karen Lechter, JD, PhD   ppt

The OTC Proposition, Mark Kreston, Squibb  htm ppt

Background & Rationale for OTC Pravachol, Dr. Jerome Cohen, MD, Squibb  htm ppt

Pravachol Safety, Dr. Rene Belder, MD, Squibb  htm ppt

Pravachol 10 OTC Program, Dr. Carola Friedman, MD, Squibb  htm ppt

Pravachol Education & Marketing Program, Patricia Kriger, Squibb  htm ppt

Conclusion, Carola Friedman, MD, Squibb  htm ppt

Potential Risks & Benefits of OTC Pravachol 10mg   ppt