NONPRESCRIPTION DRUGS ADVISORY COMMITTEE AND

ARTHRITIS ADVISORY COMMITTEE

July 20, 1999

FLEXERIL MR

NDA 21070

Agenda

Introduction

Roster

Questions

Part I (Guide to Reader, Table of Contents, Pages 1-62)

Part II (Pages 63 – Appendix I)

EXECUTIVE SUMMARY

Attachment A to Executive Summary

Medical Officer Review, HFD-550

Safety Review, Medical Officer Review, HFD-560

Attachment 1 to the Safety Review

Attachment II to the Safety Review

Attachment III Part 1 to the Safety Review

Attachment III Part 2 to the Safety Review

Pharmacokinetic Review (Clinical Pharmacology/ Biopharmaceutics Review)

Statistical Summary

Neurologic Impact Review

Abuse Potential Review

Label Comprehension Review