Pharmaxis Ltd. said the U.S. Food and Drug Administration approved its Sydney-based manufacturing facility for the production of Aridol, an asthma diagnostic product.
In 2011, the FDA approved Aridol to help doctors diagnose and manage asthma in patients aged 6 years and older. The drug was withdrawn from the U.S. market as part of the company's corporate restructuring in 2013.
The Australian company will initiate the U.S. relaunch of Aridol in the fourth quarter through Methapharm Inc., its exclusive distribution partner.
The manufacturing facility now produces Aridol for markets in Europe, Australia and South Korea. It is also where Pharmaxis manufactures Bronchitol, an approved treatment for certain patients with cystic fibrosis developed to help clear mucus from their lungs.