Food and Drug Administration
January 13 - 14, 2005
Merck & Co.
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)
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.
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)
Attachment C1. Label Comprehension Study Screening Questionnaire, FDA (PDF)