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



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