Printer Friendly
The Free Library
14,529,525 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

IVAX Receives New Drug Approval for Proprietary Asthma Product.


MIAMI -- IVAX Corporation (AMEX AMEX

See: American Stock Exchange
: IVX, LSE LSE - Language Sensitive Editor : IVX.L) received approval 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 its patented HFA (CFC-free) formulation of 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.
 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. ) 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 CFC

See: Controlled foreign corporation
 albuterol is removed from the U.S. market, now anticipated in 2006."

Albuterol is a 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.
 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 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 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.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:Nov 1, 2004
Words:587
Previous Article:When Consumers Shop for Luxuries, They Prefer Traditional Department Stores, Reports Unity Marketing.
Next Article:CAS Announces Alliance with SAS; Collaboration Will Drive Improved Trade Promotion Management in CPG Industry.
Topics:



Related Articles
IVAX Signs Product Collaboration and Development Services Agreement With Bristol-Myers Squibb.
IVAX GETS APPROVAL TO MARKET PAXENE IN CANADA.(Brief Article)(Statistical Data Included)
IVAX BEGINS PHASE II STUDY FOR BPH DRUG.
DRUG MERGER SET : ANNOUNCED DEAL OF WHOLESALER BERGEN BRUNSWIG, MAKER IVAX SENDS COMPANIES' STOCKS TUMBLING.(BUSINESS)(Statistical Data Included)
IVAX Acquires Pharmaceutical Business in France.
IVAX Receives Pediatric Approval for QVAR.
IVAX Receives Approval For Easi-Breathe Asthma Product in Germany.
IVAX Submits New Drug Application For CFC-Free Albuterol Metered Dose Inhaler For Asthma.
IVAX Wins 2003 Business Development Strategy Award.
IVAX Receives U.K. Approval For QVAR In Easi-Breathe Inhaler.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles