Novartis Resubmits Onbrez To FDA; Touts Comparative Trial Against Spiriva
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Novartis AG, looking to position its once-daily Onbrez Breezhaler (indacaterol) to steal market share from the only once-daily bronchodilator approved for chronic obstructive pulmonary disease, Boehringer Ingelheim GMBH/Pfizer Inc.’s Spiriva (tiotropium), released Phase III data from a head-to-head study comparing the two products.