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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