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news.Pharmaxis Inc, a wholly owned subsidiary of Pharmaxis Ltd, a respiratory specialty pharmaceutical company, has filed a new drug application, electronically, with the FDA for Aridol. Bronchial challenge tests are designed to assess bronchial hyperresponsiveness, an important marker in the diagnosis and assessment of asthma.
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Aridol will be a standardized test kit containing proprietary dry-powder mannitol (a naturally occurring sugar alcohol), prepared for delivery to the lungs using a proprietary hand-held inhaler.
The goal of Aridol is to provide physicians and healthcare professionals with an objective measure of active airway inflammation through an easy-to-use, single-use test for asthma care and assessment in a variety of healthcare settings, said Pharmaxis.
Aridol is approved for sale in Australia, major European countries and Korea. It is the first and only bronchial challenge test approved Europe-wide, said Pharmaxis.
Brett Charlton, medical director at Pharmaxis Ltd, said: “Aridol is designed to measure bronchial hyperresponsiveness that corresponds with airway inflammation, an important underlying component of asthma.”