Abbott Isuprel
Executive Summary
Statement added to labeling that "safety and efficacy of isoproterenol in pediatric patients have not been established." The supplemental NDA for the heart block injection product was approved May 4 and includes the statement in the "Pediatric Use" portion of the "Precautions" section. The labeling change was made in response to a 1994 FDA rule requiring products that lack sufficient information for a pediatric indication or use statement include the stipulation