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OTC Emergency Asthma Inhaler NDA Survives, Needs Additional Studies

This article was originally published in The Tan Sheet

Executive Summary

FDA’s request for additional data on Armstrong’s NDA for Primatene HFA – a breath-triggered, epinephrine inhalation aerosol – shows the agency’s interest in expanding consumers’ choices for OTC emergency asthma inhalers beyond the one currently available, racepinephrine with a battery-powered atomizer.

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