Novartis Pediatric Post-Market Plans For Xolair Fall Short Of FDA Request

A post-market program designed by Novartis to control Xolair (omalizumab) in the 6-11 pediatric population was not adequate to convince FDA or its Pulmonary-Allergy Drugs Advisory Committee to extend the indication for use in moderate to severe allergy/asthma patients below 12 years of age