Ivax Corporation has received approval from the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for its patented HFA (CFC-free) formulation of albuterol in a metered dose inhaler (MDI) for the treatment of asthma.
The product will be marketed by Ivax' US proprietary products subsidiary, Ivax Laboratories, Inc. Ivax has previously received an approvable letter from the FDA on its NDA for albuterol HFA (CFC-free) in patented, breath-activated inhaler, known in Europe as Easi-Breathe.
Neil Flanzraich, vice chairman and president of Ivax Corporation, said, "Products for treating respiratory disease have become an important part of our worldwide business and this is the first US approval of an Ivax proprietary asthma product. This MDI and its breath-operated version will be of great commercial importance to Ivax, even more so when CFC albuterol is removed from the US market, now anticipated in 2006."
Albuterol is a bronchodilator widely-used as a "rescue" medication for the relief of asthma symptoms. Hydrofluoroalkanes (HFAs) are propellants that will replace the chlorofluorocarbons (CFCs) propellants that are harmful to the ozone layer. In June 2004, the FDA issued a proposed rule for the removal of CFC albuterol products from the US market.
Ivax currently sells Qvar the only CFC-free aerosol corticosteroid on the US market to treat asthma. Corticosteroids are used as "maintenance" drugs to prevent asthma attacks. With the approval of our CFC-free albuterol, Ivax now has a family of CFC-free aerosol products for asthma patients, the company release said.