Joint session of the

Nonprescription Drugs Advisory Committee

and the

Endocrinologic and Metabolic Drugs Advisory Committee

January 13 and 14, 2005

NDA 21-213- proposing over-the-counter Mevacor™(lovastatin) 20mg

Index

Tab 1 Discussion Points to Consider

Tab 2 Background

v Attachment 1: Guidance to Industry

v Attachment 2: NCEP ATP-III Guidelines

v Attachment 3: NCEP report/update to NCEP ATP-III

v Attachment 4: Abstract from Ahmed F. and Jacobson IM

v Attachment 5: Publication – Chalasani et al.

v Attachment 6: Letter from Dr. Paul Watkins

v Attachment 7: Letter from Dr. Keith Tolman

Tab 3 Memo: Statistical Review (AFCAPS/TexCAPS)

Tab 4 Memo: Pharmacology/Toxicology Review (Pregnancy Category X)

Tab 5 Memo: Consumer Behavior Issues Related to the Marketing of Mevacor OTC

Tab 6 Review of the Mevacor™ OTC Label Comprehension Study

v Executive Summary

v Label Comprehension Study Review

v Attachment 1: Questions from Label Comprehension Study

Tab 7 Consumer Behavior Safety Data (Review of the CUSTOM Actual Use Study)

Tab 8 Draft Label