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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.

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