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Novel COPD Exercise Claims Eluded Boehringer In Bid to Differentiate Striverdi

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Sponsor’s claimed impact on exercise tolerance was not adequately supported and should not serve as a marketing advantage for the chronic obstructive pulmonary disease drug, FDA review staff said. However, Boehringer Ingelheim’s failed attempt for the exercise-related labeling language spurred the agency to clarify the types of studies and endpoints that potentially could support such claims.

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