Aridol is a lung function test and the world's first approved indirect challenge test for asthma. The Aridol lung function test, developed by Australian researchers and Pharmaxis, helps doctors more accurately determine the severity of a patient's airways inflammation - a hallmark of asthma - and allow prescription of the right amount of medication. The 15-25 minute test uses powdered mannitol, which the patient inhales in increasing doses. In asthmatic patients, this causes the airways to narrow and contract, which is detected by measuring the amount of air a person can exhale in one second. The smaller the dose required to cause contraction, the more severe the patient's asthma.
Pharmaxis, Inc. today announced that the Centers for Medicare and Medicaid Services (CMS) has assigned a product-specific billing code, or J-code, for ARIDOL (mannitol inhalation powder) Bronchial Challenge Test Kit.
Pharmaceutical company Pharmaxis today announced the Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the granting of a Marketing Authorisation for Bronchitol, clearing the way for the product to be used in Europe "for the treatment of cystic fibrosis in adults as an add-on therapy to best standard of care."
Pharmaxis, a global specialty pharmaceutical company focused on therapeutic products for respiratory and immune disorders, will present ARIDOL™ (mannitol inhalation powder) Bronchial Challenge Test Kit, at the 2010 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI), November 11-16 in Phoenix, AZ.
Pharmaceutical company Pharmaxis today announced significant results of pooled data from its two large scale six month Phase III trials of Bronchitol (inhaled mannitol) in people with cystic fibrosis.
Pharmaxis, a global specialty pharmaceutical company focused on therapeutic products for chronic respiratory and immune disorders, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market ARIDOL™ (mannitol inhalation powder) Bronchial Challenge Test Kit, the first new bronchial challenge test in more than two decades.
Pharmaxis has announced it had received notification from the United States Food and Drug Administration (FDA) that the New Drug Application (NDA) for its mannitol bronchial challenge test Aridol has been accepted for standard review. The FDA will advise the result of the review on 27 December 2009.
Pharmaxis, Inc., a wholly owned subsidiary of Pharmaxis Ltd , an emerging respiratory specialty pharmaceutical company, announced today that it has filed a New Drug Application (NDA), electronically, with the U.S. Food and Drug Administration (FDA) for Aridol (mannitol bronchial challenge test).
Pharmaxis Ltd today announced that it has received national approval to market Aridol in Germany.
Pharmaxis has announced its first step into the Asian market, filing for Korean marketing approval of its lung function test Aridol.