Proposed Agenda:    Tuesday, July 20, 1999 

Joint Meeting:  Nonprescription Drugs and Arthritis Advisory Committees


Food and Drug Administration

Holiday Inn, Gaithersberg, Maryland


8:30    Call to Order, Introductions

Eric P. Brass, M. D., Ph.D., Chair, NDAC, Acting Committee Chair


            Conflict of Interest Statement

Sandra Titus, Ph.D., Executive Secretary, NDAC



John Hyde, M.D., Ph.D., Acting Deputy Director of Anti-Inflammatory, Analgesics and Opthalmic Drug Products (DAAO)


Issue:  Consideration of NDA 21-070, Flexeril 5mg (cyclobenzaprine HCL) Merck


8:45    FDA Presentations                                   


           Background and Efficacy

James Witter, M.D., Ph.D., Medical Officer, DAAO        


 Neurologic Impact 

 Paul Andreason, M.D.,Medical Officer, Neuropharm     


 Abuse Potential  

 Michael Klein, Ph.D., Senior Interdisciplinary Scientist, Controlled Substance



 Rosemarie Neuner, M.D.,Medical Officer, Over-the-Counter  (OTC)   


 Label Comprehension

 Kathryn Aikin, Ph.D. Regulatory Review Officer for OTC, DDMAC      


10:00  Break


10:15 Merck Presentations



Edwin Hemwall, PhD, Regulatory Affairs, Merck


Review of Flexeril OTC Development Program

Scott Korn, M.D. Clinical Research, Merck


11:30  Questions from Advisory Committees


12:00  Lunch


1:00    Open Public Hearing


2:00    Charge to the Committee

Linda Katz, M.D., M.P.H., Deputy Director of OTC, ODE V