Flexeril Indications, Warnings Well Understood In Label Comprehension Trial
This article was originally published in The Tan Sheet
Executive Summary
The proposed indications and warnings for Merck's Rx-to-OTC switch candidate Flexeril (cyclobenzaprine 5 mg) were among the label elements well understood by subjects in a label comprehension study conducted in support of the switch. Results of the trial were presented at the July 20 meeting of FDA's Nonprescription Drugs and Arthritis Advisory Committees in Gaithersburg, Md.