Aridol receives complete response

Pharmaxis Ltd. (ASX:PXS) received a complete response letter from FDA for an NDA for Aridol mannitol powder inhalation test to assess bronchial hyperresponsiveness (BHR) to aid in the diagnosis of patients six years of age and older with symptoms of asthma or suggestive of asthma. In the letter, FDA listed deficiencies at three subcontract manufacturing and testing facilities and requested revised labeling and agreement on postmarketing requirements. The company said the agency did not ask for any new clinical trials.

Last month, FDA's Pulmonary-Allergy Drugs Advisory Committee supported approval of the test. Aridol is marketed in Australia and nine European countries (See BioCentury, Nov. 23, 2009). ...