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Armstrong preps OTC inhaler IND

This article was originally published in The Tan Sheet

Executive Summary

Generics manufacturer Armstrong Pharmaceuticals expects to file in September an investigational new drug application for an epinephrine inhaler that uses hydrofluoroalkane - a month earlier than expected, according to a presentation prepared by the firm. Roxbury, Mass.-based Armstrong says in the presentation the new formula will better deliver epinephrine than the current Primatene Mist formula, which uses chlorofluorocarbons. An FDA final rule dictates firms remove from the market epinephrine meter-dosed inhalers and other drugs with CFCs or other ozone-depleting substances by the end of 2011 (1"The Tan Sheet" Nov. 24, 2008). Primatene Mist and generic equivalents are the only FDA-approved OTC drug for bronchial asthma. Armstrong aims to launch the new formula, which would comply with the FDA rule, before the 2011 deadline to ensure continued access to an OTC epinephrine MDI, according to the slides. The firm will make the presentation Sept. 25 at an FDA public workshop to discuss alternatives to OTC epinephrine MDIs (2"The Tan Sheet" Aug. 24, 2009)

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