Food and Drug Administration
Joint Meeting of the
and the
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]