Food and Drug Administration

Joint Meeting of the

Nonprescription Drugs Advisory Committee

and the

Endocrinologic and Metabolic Drugs Advisory Committee

January 13 , 2005

Slides

Introduction: Non-Prescription Mevacor 20 mg Joint Advisory Committee Meeting, NDA 21-213, Charles J Ganley, MD, Food and Drug Administration [htm] [pdf] [ppt]

Non-Prescription Mevacor 20 mg Joint Advisory Committee Meeting, NDA 21-213, Mary H Parks, MD, Food and Drug Administration [htm] [pdf] [ppt]

Introduction, Edwin L Hemwall, PhD, Johnson & Johnson - Merck Consumer Pharmaceuticals [htm] [pdf] [ppt]

Backup Information, Merck Consumer Pharmaceuticals (HTM) (PDF)

Overview of Lovastatin Nonclinical Developmental Data; Karen Davis-Bruno, PhD, Food and Drug Administration [htm] [pdf] [ppt]

Pivotal Label Comprehension Study Mevacor OTC, Capt Laura Shay , RN, MS, C-ANP, Food and Drug Administration [htm] [pdf] [ppt]

Mevacor Daily 20 mg Tablets Rx-to-OTC Switch, Daiva Shetty, MD, Food and Drug Administration [htm] [pdf] [ppt]

Nonprescription Simvastatic in the United Kingdom, Michael L Koenig PhD, Food and Drug Administration [htm] [pdf] [ppt]