Ivax Corporation has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval to market albuterol sulfate using a non-ozone depleting HFA (hydrofluoroalkane) propellant in a metered dose inhaler (MDI), the company announced.
Albuterol is a widely used beta-agonist bronchodilator for the relief of asthma symptoms and is the primary rescue medication for asthma sufferers. Over 90 per cent of the more than 40 million albuterol inhalers sold in the U.S. last year contained CFC propellants, which are expected eventually to be removed from the market due to concern about ozone depletion.
"The submission of this NDA is an important step in expanding Ivax' asthma franchise in the U.S. We currently market QVA, a novel HFA formulation of beclomethasone which was the first and is still the only CFC-free aerosol corticosteroid for asthma on the U.S. market," said Neil Flanzraich, vice chairman and president of Ivax. "Ivax is pleased to be a leader in introducing environmentally friendly asthma medicines throughout the world."
In 1997, Ivax became the first company in the world to receive approval to market CFC-free beclomethasone. Ivax has since received numerous approvals around the world for CFC-free beclomethasone and CFC-free albuterol in both an MDI and in Ivax' patented Easi-Breathe inhaler. Ivax also intends to submit an NDA for CFC-free albuterol in our Easi-Breathe inhaler, considered by many to be the finest breath-activated aerosol inhaler in the world.