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Novartis Resubmits Onbrez To FDA; Touts Comparative Trial Against Spiriva

This article was originally published in The Pink Sheet Daily

Executive Summary

The once-daily COPD treatment, already approved in Europe with ho-hum sales, is a lynchpin of Novartis' plan to establish a respiratory franchise.

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Bronchodilator is approved for COPD at a 75 mcg dose, compared to 150 mcg and 300 mcg in Europe. Label nods to quality-of-life data.

Novartis Finally Wins Arcapta Approval, Having Lost Battle On Desired Dose

Bronchodilator is approved for COPD at a 75 mcg dose, compared to 150 mcg and 300 mcg in Europe. Label nods to quality-of-life data.

COPD Drug Dose Selection May Face Greater Scrutiny In Arcapta’s Wake

FDA’s lingering concerns about the appropriate dose for Novartis’ chronic obstructive pulmonary disease therapy Arcapta Neohaler (indacaterol) suggest the agency will take a harder line on dosing data requirements for new COPD treatments, particularly when they have not first been approved in asthma.

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