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FDA Approves Pharmaxis' ARIDOL™ (Mannitol Inhalation Powder) Bronchial Challenge Test Kit for the Assessment of Bronchial Hyperresponsiveness
Date:10/6/2010

bronchial challenge test in non-asthmatic patients with symptoms suggestive of asthma and clinically diagnosed asthmatic patients six years of age and older.  Approved for use in 19 countries, ARIDOL has been used by more than 44,000 patients, and is marketed in Australia, major European countries and Korea.  

ARIDOL is included in official international guidelines for the clinical assessment of asthma. Organizations and guidelines endorsing ARIDOL include: the International Olympic Committee Medical Commission's Independent Panel, the U.S. Asthma Management Guidelines, the Global Initiative for Asthma (GINA) Report on Global Strategy for Asthma Management and Prevention, the World Anti-Doping Agency and the Australian Asthma Management Handbook.

ARIDOL is the only dry powder bronchial challenge test approved for use in the U.S.

Indication

Mannitol, the active ingredient in ARIDOL, is a sugar alcohol indicated for the assessment of bronchial hyperresponsiveness in patients 6 years of age or older who do not have clinically apparent asthma.  

ARIDOL is not a stand alone test or a screening test for asthma.  Bronchial challenge testing with ARIDOL should be used only as part of a physician's overall assessment of asthma.

Important Safety Information

WARNING: RISK OF SEVERE BRONCHOSPASM

Mannitol, the active ingredient in ARIDOL, acts as a bronchoconstrictor and may cause severe bronchospasm.  Bronchial challenge testing with ARIDOL is for diagnostic purposes only.  Bronchial challenge testing with ARIDOL should only be conducted by trained professionals under the supervision of a physician familiar with all aspects of the bronchial challenge test and the management of acute bronchospasm. Medications (such as short acting inhaled beta-agonist) and equipment to treat severe bronchospasm must be present in the testing area.  If severe bronchospasm occurs it
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