Pharmaxis Submits New Drug Application for Aridol to FDA
Release Date: 02/03/2009 12:00am
Pharmaceutical company Pharmaxis (ASX:PXS, NASDAQ:PXSL) today announced it had
submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Aridol, a bronchial challenge test. Bronchial challenge tests are designed to help in the correct diagnosis and assessment of asthma. The structure and content of the NDA was based on a pre-NDA meeting with the FDA and follows the completion of two international randomized pivotal Phase 3 trials with Aridol involving over 1,000 subjects.