ZENECA ACCOLATE DRUG INTERACTION STUDIES SHOULD BE PERFORMED PRIOR TO RECONSIDERATION FOR APPROVAL; ASTHMA DRUG VOTED DOWN 6-3 BY ADVISORY CMTE.
Executive Summary
Zeneca's Accolate (zafirlukast) should undergo additional drug interaction studies for mild to moderate asthma patients before the leukotriene antagonist should be reconsidered for approval, FDA's Pulmonary-Allergy Drugs Advisory Committee said March 28.