Mevacor Rx-to-OTC Switch
Executive Summary
Joint meeting of FDA's Nonprescription Drugs and Endocrinologic & Metabolic Drugs Advisory Committees confirmed for Jan. 13-14 to review Johnson & Johnson/Merck's NDA (21-213) for over-the-counter switch of Mevacor (lovastatin). The committee will review the 20 mg/day dose for the reduction of low-density lipoprotein cholesterol to prevent first heart attack. The meeting will be held at the Holiday Inn in Bethesda, Md. beginning at 8 a.m. [Editor's Note: To 1watch a webcastor order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]...