Ivax Corporation has received an approvable letter from the US FDA for its New Drug Application (NDA) for albuterol sulfate using non-ozone-depleting, CFC-free propellant in Ivax' patented breath-activated aerosol inhaler, a company release said.
Albuterol, a beta-agonist bronchodilator, is the primary rescue medicine for the relief of asthma symptoms. Over 90 per cent of the more than 50 million albuterol inhalers sold in the US 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, the breath-activated aerosol inhaler has good market in the UK. 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, the release says.
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.