IVAX Receives FDA Approvable Letter for Albuterol HFA in Breath-Activated Inhaler.MIAMI -- IVAX Corporation (AMEX AMEX See: American Stock Exchange :IVX)(LSE LSE - Language Sensitive Editor :IVX.L) announced today that it has received an approvable letter from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for its New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for albuterol sulfate using non-ozone-depleting, CFC-free propellant in IVAX' patented breath-activated aerosol inhaler. Albuterol albuterol /al·bu·ter·ol/ (al-bu´ter-ol) a ß agonist used as the base or sulfate salt as a bronchodilator. al·bu·ter·ol n. , a beta-agonist bronchodilator bronchodilator /bron·cho·di·la·tor/ (-di´la-ter) 1. expanding the lumina of the air passages of the lungs. 2. an agent which causes dilatation of the bronchi. , 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 CFC See: Controlled foreign corporation ) 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 Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. , 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 (1) (Multiple Document Interface) A Windows function that allows an application to display and lets the user work with more than one document at the same time. ) 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. |
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