IVAX Receives FDA Approvable Letter for Albuterol HFA in Breath-Activated Inhaler

Business Wire, July 7, 2004

MIAMI -- IVAX Corporation (AMEX: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.

Copies of this and other news releases may be obtained free of charge from IVAX' website at http://www.ivax.com.

Except for the historical matters contained herein, statements in this press release, including statements relating to IVAX' approvable letter for albuterol sulfate using a non-ozone depleting HFA (hydrofluoroalkane) propellant in its breath-activated inhaler, are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties which may affect the company's business and prospects, including the risks that IVAX may not receive final approval for albuterol sulfate using a non-ozone depleting HFA propellant in its breath-activated inhaler or that its launch will be delayed; that IVAX may not receive final approval for albuterol sulfate using a non-ozone depleting HFA propellant in a metered dose inhaler (MDI) or that its launch will be delayed; the difficulty of predicting the timeliness or outcome of product development efforts and regulatory applications; FDA and other requisite regulatory authorizations may be achieved later than anticipated or not at all; market acceptance and demand for IVAX' respiratory products may not be as anticipated; that CFC propellants may not be removed from the market; and the impact of competitive products and pricing and successful compliance with extensive, costly, complex and evolving governmental regulations and restrictions. In addition to the risk factors set forth above, IVAX' forward looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, trade buying patterns, patent positions and litigation, among other things. For further details and discussion of these and other risks and uncertainties, see IVAX' Annual Report on Form 10-K and other filings with the Securities and Exchange Commission.