Novartis’ Foradil 24 Mcg Dose Shows Improved Efficacy; Safety Questioned
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Foradil 24 mcg appears to offer a slight efficacy advantage over 12 mcg and would be approvable if Novartis could adequately address concerns about severe asthma exacerbations, Marianne Mann, MD, deputy director of the Division of Pulmonary and Allergy Drug Products, said in a Feb. 2 review of the Foradil NDA. The aerolized asthma drug was approved in a 12 mcg dose on Feb. 16.