IVAX Receives FDA Approvable Letter for Albuterol HFA in Breath-Activated Inhaler
7/7/2004 5:00:00 AM
MIAMI, Jul 7, 2004 (BUSINESS WIRE) -- IVAX Corporation (IVX)(LSE:IVX.L) announced today that it has received an approvable letter from the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for albuterol sulfate using non-ozone-depleting, CFC-free propellant in IVAX' patented breath-activated aerosol inhaler.
Albuterol, a beta-agonist bronchodilator, is the primary rescue medicine for the relief of asthma symptoms. Over 90% of the more than 50 million albuterol inhalers sold in the U.S. last year contained chlorofluorocarbon (CFC) propellants, which are expected to be eventually removed from the market due to concern about ozone depletion. On June 16, 2004, the FDA issued a proposed rule to remove the essential-use designation for CFC albuterol inhalers. IVAX' formulation of albuterol uses hydrofluoroalkane (HFA), a non-ozone-depleting, CFC-free propellant.
IVAX' patented breath-activated aerosol inhaler, marketed in Europe under the name Easi-Breathe(R), is the best-selling breath-activated aerosol inhaler in the United Kingdom, the world's second largest asthma market. This inhaler eliminates the need to coordinate the manual release of the medicine with inhalation of the medicine, which is required by standard metered dose inhalers. Such coordination can be difficult and sub-optimal synchronization can result in the medicine not reaching the lungs.
Upon receipt of final FDA approval, IVAX will market this product through its wholly owned subsidiary, IVAX Laboratories, Inc. IVAX has previously received an approvable letter from the FDA on a separate NDA for an HFA formulation of albuterol in a standard metered dose inhaler.
IVAX Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary products in the U.S. and internationally. |
