IVAX Receives New Drug Approval for Proprietary Asthma Product

Business Wire, Nov 1, 2004

MIAMI -- IVAX Corporation (AMEX: IVX, LSE: IVX.L) received approval from the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for its patented HFA (CFC-free) formulation of albuterol in a metered dose inhaler (MDI) for the treatment of asthma. The product will be marketed by IVAX' U.S. proprietary products subsidiary, IVAX Laboratories, Inc. IVAX has previously received an approvable letter from the FDA on its NDA for albuterol HFA (CFC-free) in our patented, breath-activated inhaler, known in Europe as Easi-Breathe(R).

Neil Flanzraich, vice chairman and president of IVAX Corporation, said, "Products for treating respiratory disease have become an important part of our worldwide business and this is the first U.S. approval of an IVAX proprietary asthma product. This MDI and its breath-operated version will be of great commercial importance to IVAX, even more so when CFC albuterol is removed from the U.S. market, now anticipated in 2006."

Albuterol is a bronchodilator widely-used as a "rescue" medication for the relief of asthma symptoms. Hydrofluoroalkanes (HFAs) are propellants that will replace the chlorofluorocarbons (CFCs) propellants that are harmful to the ozone layer. In June, 2004, the FDA issued a proposed rule for the removal of CFC albuterol products from the U.S. market.

IVAX currently sells QVAR(R) the only CFC-free aerosol corticosteroid on the U.S. market to treat asthma. Corticosteroids are used as "maintenance" drugs to prevent asthma attacks. With the approval of our CFC-free albuterol, IVAX now has a family of CFC-free aerosol products for asthma patients.

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 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 a metered dose inhaler (MDI), 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 the launch of albuterol sulfate using a non-ozone depleting HFA propellant in an MDI will be delayed; 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 may 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 in 2006 or ever; 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.