Food and Drug Administration

Joint meeting of the Nonprescription Drugs Advisory Committee and Endocrinological and Metabolic Drugs Advisory Committee

July 13, 2000

Slides

MevacorŪ NDA 21-213, lovastatin

Clinical Efficacy and Safety Review, Mary H Parks, MD, FDA   ppt  

Actual Use Trials, Andrea Leonard-Segal, MD,  FDA   ppt

Mevacor CC Label Comprehension Study 201, Karen Lechter, JD, PhD   ppt

Mevacor Lovastatin 10 mg, Dr. Eve Slater, MD, Merck Laboratories  htm  ppt

Benefit of Lovastatin 10 mg, Dr. Polly Beere, MD, Merck Laboratories htm ppt

Postapproval Studies, Potential Concerns, & OTC Studies of Lovastatin 10 mg, Dr. Scott Korn, MD, Merck Laboratories  htm  ppt

MEVACOR OTC Label Development  and Consumer Behavior, Dr. Edwin Hemwall, PhD, Merck Laboratories  htm  ppt