FDA Panel Turns Down Expanded Indication For Ezetimibe

An FDA advisory panel on Monday voted 10-5 against an expanded indication for Merck’s ezetimibe (Vytorin, Zetia). The current label states that the drugs have not been shown to improve cardiovascular morbidity or mortality. The proposed expanded indication was based on findings from the IMPROVE-IT trial. The panel spent most of the day trying to interpret...Click here to continue reading...
Source: CardioBrief - Category: Cardiology Authors: Tags: Prevention, Epidemiology & Outcomes People, Places & Events Policy & Ethics cholesterol ezetimibe vytorin Merck FDA advisory panel Zetia IMPROVE-IT Source Type: blogs