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