Joint Meeting of

NONPRESCRIPTION DRUGS ADVISORY COMMITTEE

and

ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE

July 13, 2000

Mevacor NDA 21-213, Lovastatin, 10 mg

Merck and Company

Disclaimer

The statements contained in this document 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.

Briefing Information

Food and Drug Administration

OPDRA Postmarketing Safety Review

OPDRA Safety Review

June 9, 2000 Memorandum regarding proposed Rx to OTC switch for Lovastatin (Mevacor)

Medical Officer's Draft Review of New Drug Application

Clinical Pharmacology & Biopharmaceutics Review

Statistical Review and Evaluation

Draft Summary of Repro-Tox Studies

DDMAC Review

OTC Medical Officer's Review