MIAMI--(BUSINESS WIRE)--Dec. 1, 2003--IVAX Corporation (AMEX:IVX - News; LSE:IVX.L - News) announced today 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% of the more than 40 million albuterol inhalers sold in the U.S. 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 U.S. and internationally.
Copies of this and other news releases may be obtained free of charge from IVAX' Web site at http://www.ivax.com.
Except for the historical matters contained herein, statements in this press release 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 Research, Inc. may not receive final approval for albuterol sulfate using a non-ozone depleting HFA (hydrofluoroalkane) propellant in a metered dose inhaler or that its launch will be delayed; the difficulty of predicting the timeliness or outcome of product development efforts and the filing of 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; clinical trials for the Easi-Breathe device may not generate data that would support the approval or marketing of this product for the indications being studied; 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.
IVAX Corporation, Miami David Malina, 305/575-6043 http://www.ivax.com
Source: IVAX Corporation