Ivax Corporation announced it has received notification from the United States Food and Drug Administration (FDA) that its New Drug Application (NDA) for Albuterol sulfate using a non-ozone depleting HFA (hydrofluoroalkane) propellant in a metered dose inhaler (MDI) is approvable.
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 US last year contained CFC propellants, which are expected eventually to be removed from the market due to concern about ozone depletion.
Ivax will market this product through its wholly owned subsidiary, Ivax Laboratories, Inc., upon receipt of final approval. Ivax has also submitted a New Drug Application (NDA) to the FDA for approval to market a CFC-free formulation of Albuterol in Ivax' patented Easi-Breathe inhaler. Ivax Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary and diagnostic products in the US and internationally.