FDA accepts Aridol NDA resubmission

FDA accepted for review an NDA resubmission from Pharmaxis Ltd. (ASX:PXS) for Aridol mannitol powder inhalation test to assess bronchial hyperresponsiveness as an aid in the diagnosis of patients six years of age and older with symptoms of asthma or suggestive of asthma. Pharmaxis expects a decision within six months. The resubmission includes a safety update, revised labeling and additional CMC information that was requested in the agency's December complete response letter. Last November, FDA's Pulmonary-Allergy Drugs Advisory Committee supported approval of the test (See BioCentury, Nov. 23, 2009). ...