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BI’s Olodaterol Wants Novel Exercise Claims In COPD

This article was originally published in The Pink Sheet Daily

Executive Summary

Proposed claims for Striverdi Respimat include improved exercise tolerance and increased inspiratory capacity, but FDA has no clear regulatory pathway for them.

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Boehringer’s Novel Exercise Claims In COPD May Spur FDA Action To Clarify Requirements

Company was hoping for an exercise tolerability claim for olodaterol, but members of the Pulmonary-Allergy Drugs Advisory Committee questioned several aspects of the trials and suggested FDA issue guidance on the matter.

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Boehringer’s Olodaterol Will Have To Pass LABA Hurdles At January Advisory Committee

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