Primatene OTC Asthma Inhaler Slated For FDA Advisory Panel
This article was originally published in The Pink Sheet Daily
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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Armstrong Pharmaceuticals waits to learn the fate of its recently submitted NDA for reformulated Primatene Mist, and Nephron Pharmaceuticals contests FDA’s September warning that its Asthmanefrin is an unapproved drug.
Nephron Pharmaceuticals makes its racepinephrine-containing Asthmanefrin, previously marketed only to health care professionals, available as the only OTC inhaler. The product likely will be alone on the market until Amphastar Pharmaceuticals’ planned launch in 2013 of a reformulated Primatene Mist inhaler.
Armstrong Pharmaceuticals plans to submit in the fourth quarter an NDA to FDA for an OTC asthma inhaler reformulated without chlorofluorocarbon as a propellant. The House Energy and Power Subcommittee proposes allowing the firm to sell its remaining inventory of CFC-containing Primatene Mist.