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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.

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