Food and Drug Administration

Nonprescription Drugs Advisory Committee

and the

Endocrinologic and Metabolic Drugs Advisory Committee

January 13 - 14, 2005

Briefing Information

Merck & Co.

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Cover Letter, Merck & Co., Inc. (PDF)

Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use, Form FDA 356h, Merck & Co., Inc. (PDF)

Background Information - Mevacor™ OTC (nonprescription Iovastatin 20 mg), Merck & Co., Inc. (PDF)

FDA

Disclaimer

Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. 552). These redacted portions will appear as white space on the screen or on the printed page.

In addition, for this particular document, a technical problem with the software has resulted in a misnumbering of the pages. In Tab 7 of the FDA briefing document, page 66 is followed immediately by page 74. This is strictly a problem with the page numbering, and no text has been deleted from the document.

FDA Index (HTM) (PDF) (Word)

Tab 1. Discussion Points, FDA (HTM) (PDF) (Word)

Tab 2. Background Information, FDA (HTM) (PDF) (Word)

Attachment 1. Guidance for Industry - OTC Treatment of Hypercholesterolemia, FDA (PDF)

Attachment 2. Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, FDA (PDF)

Attachment 6. General Clinical Research Center, Dr. Jeffery Levine (PDF)

Attachment 7. Letter From Dr. Keith Tolman, University of Utah to Dr. Jeffrey Levine Regarding Issues Regarding Use of Statins in Patients With Live Disease and Possible Prospective Study, FDA (PDF)

Tab 3. Statistical Review (HTM) (PDF) (Word)

Tab 4.Pharmacology/Toxicology Review, FDA (HTM) (PDF) (Word)

Tab 5. Memorandum From Dr. Charles Ganley Regarding Consumer Behavior Issues Related to the Marketing of Mevacor OTC, FDA (HTM) (PDF) (Word)

Tab 6. Executive Summary (HTM) (PDF) (Word)

Tab 6. Label Comprehension Study #90-NG Review, FDA (HTM) (PDF) (Word)

Attachment C1. Label Comprehension Study Screening Questionnaire, FDA (PDF)

Tab 7. Consumer Behavior and Safety Data, FDA (HTM) (PDF) (Word)

Tab 8. Draft Label, FDA (HTM) (PDF) (Word)