Bracco LumenHance GI imaging agent pediatric supplement to be filed within six months of Dec. 19 approval.

Executive Summary

BRACCO LUMENHANCE PEDIATRIC SUPPLEMENT WILL BE FILED WITHIN SIX MONTHS of the contrast agent's Dec. 19 approval, the company and FDA agreed. The supplement will contain pediatric dosing recommendations based on oral volume information contained in medical references and literature. One issue the company will evaluate is whether to decrease the adult dose or to dose according to body mass. Bracco noted that after LumenHance (manganese chloride) is launched, the company plans to create an open registry of pediatric patients.