Ivax Corporation has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval to market a CFC-free formulation of albuterol in Ivax' patented Easi-Breathe inhaler. Already marketed successfully in several countries around the world, the Easi-Breathe inhaler eliminates the need to coordinate the release of the medication and its inhalation. Such coordination, required by standard metered dose inhalers, can be a troublesome for some patients, particularly the young and elderly.
Easi-Breathe is the best selling breath-activated aerosol inhaler in the United Kingdom, the world's second largest asthma market. Albuterol is the most widely used "rescue" medicine taken by asthma sufferers for acute attacks. Easi-Breathe CFC-free albuterol is the first submission of an NDA on an Ivax Easi-Breathe product in the United States. In January 2003, Ivax submitted an NDA for CFC-free albuterol in a standard metered dose inhaler and that application is pending.
"This NDA submission is an important milestone for Ivax," said Neil Flanzraich, vice chairman and president of Ivax Corporation. "We have been selling our Easi-Breathe inhalers abroad for years, and now we are bringing this important product to the U.S., the largest asthma market in the world, by far. We believe that our CFC-free Easi-Breathe product will be used by a substantial number of asthma patients and will achieve a significant market share."
Ivax has had a long-standing commitment to provide CFC-free inhalers for the treatment of asthma. In 1997, Ivax became the first company in the world to receive approval to market CFC-free beclomethasone. Today, Ivax markets CFC-free beclomethasone and CFC-free albuterol abroad in both MDI and Easi-Breathe inhalers. Over 40 million albuterol inhalers were sold in the U.S. last year; more than 90% employed CFC propellants and these are expected to be removed from the market due to concerns that CFC's contribute to the depletion of the ozone layer.
In the U.S., Ivax currently markets Qvar, a CFC-free formulation of beclomethasone dipropionate, the only CFC-free aerosol corticosteroid sold in the United States to treat asthma. While albuterol is a "rescue" medication used to treat asthma attacks, beclomethasone is a "maintenance" medicine used to prevent them.