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Nephron Launches Asthma Inhaler Into Wide Open OTC Market

This article was originally published in The Tan Sheet

Executive Summary

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.

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Primatene OTC Asthma Inhaler Slated For FDA Advisory Panel

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.

Primatene OTC Asthma Inhaler Slated For FDA Advisory Panel

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.

Primatene OTC Asthma Inhaler Slated For FDA Advisory Panel

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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