OTC Emergency Asthma Inhaler NDA Survives, Needs Additional Studies
This article was originally published in The Tan Sheet
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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