Primatene OTC Asthma Inhaler Slated For FDA Advisory Panel
This article was originally published in The Pink Sheet Daily
Executive Summary
The NDAC and Pulmonary-Allergy Drugs Advisory Committees will consider Armstrong’s NDA for Primatene HFA, a breath-triggered epinephrine inhaler. FDA also will ask NDAC about removing hand-held bulb nebulizers from the OTC bronchodilators monograph.