Mevacor OTC Actual-Use Study Data May Answer Future NDAC Questions
This article was originally published in The Tan Sheet
Executive Summary
Nearly half of high-risk patients in the Mevacor OTC actual-use study took the low-dose statin only after securing approval from a doctor, writes Eric Brass, MD/PhD, UCLA Medical Center, in a supplement to the Nov. 15 American Journal of Cardiology
You may also be interested in...
Healthcare Payers Split On Promoting OTC Statin Use – Survey
Half of healthcare payers questioned in a recent survey say they would educate members about nonprescription statins if an OTC product were to reach the market, according to a report in the November/December Journal of Managed Care Pharmacy
OTC Mevacor CUSTOM Label Illustrates New Approach Toward Approval
Proposed labeling used in J&J/Merck's actual use trial for OTC Mevacor (lovastatin 20 mg) directs individuals to obtain follow-up cholesterol testing sooner than did the firm's 2000 proposal for the switch
Mevacor Study Comparing Rx, OTC Use Is Among FDA Panel Suggestions
Merck should conduct a head-to-head comparison study of Mevacor use in prescription and over-the-counter settings, Endocrinologic & Metabolic Drugs Advisory Committee member William Tamborlane, MD, said during a review of Merck's OTC switch application for lovastatin 10 mg.