ARTICLE | Regulation

Passing the Challenge in Asthma

November 23, 2009 8:00 AM UTC

Ease of use and a positive safety profile resulted in positive panel votes for Aridol mannitol powder inhalation test from Pharmaxis Ltd. at last week's meeting of FDA's Pulmonary-Allergy Drugs Advisory Committee.

In three separate votes, the panel supported approval of Aridol to assess bronchial hyperresponsiveness (BHR) in patients 6 years of age and older to aid in the diagnosis of patients with symptoms of asthma or suggestive of asthma. The panel voted 12-3 with one abstention to support approval of Aridol for patients 18 years and older; 14-2 to support approval of Aridol in patients aged 12-17; and 11-5 in favor of Aridol in diagnosing patients 6-11 years of age...