We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Innosis Ecological Ag | TG:IVX | Tradegate | Ordinary Share |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.00 | - |
BW20030902002026 20030902T120839Z UTC ( BW)(IVAX-CORPORATION)(IVX) Research Update Business Editors UK REGULATORY NEWS MIAMI--(BUSINESS WIRE)--Sept. 2, 2003-- IVAX Submits First NDA for Easi-Breathe in U.S. IVAX Corporation (AMEX:IVX)(LSE:IVX.L) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval to market a CFC-free formulation of albuterol in IVAX' patented Easi-Breathe(R) inhaler. Already marketed successfully in several countries around the world, the Easi-Breathe inhaler eliminates the need to coordinate the release of the medication and its inhalation. Such coordination, required by standard metered dose inhalers, can be a troublesome for some patients, particularly the young and elderly. Easi-Breathe is the best selling breath-activated aerosol inhaler in the United Kingdom, the world's second largest asthma market. Albuterol is the most widely used "rescue" medicine taken by asthma sufferers for acute attacks. Easi-Breathe CFC-free albuterol is the first submission of an NDA on an IVAX Easi-Breathe product in the United States. In January 2003, IVAX submitted an NDA for CFC-free albuterol in a standard metered dose inhaler and that application is pending. "This NDA submission is an important milestone for IVAX," said Neil Flanzraich, vice chairman and president of IVAX Corporation. "We have been selling our Easi-Breathe inhalers abroad for years, and now we are bringing this important product to the U.S., the largest asthma market in the world, by far. We believe that our CFC-free Easi-Breathe product will be used by a substantial number of asthma patients and will achieve a significant market share." IVAX has had a long-standing commitment to provide CFC-free inhalers for the treatment of asthma. In 1997, IVAX became the first company in the world to receive approval to market CFC-free beclomethasone. Today, IVAX markets CFC-free beclomethasone and CFC-free albuterol abroad in both MDI and Easi-Breathe inhalers. Over 40 million albuterol inhalers were sold in the U.S. last year; more than 90% employed CFC propellants and these are expected to be removed from the market due to concerns that CFC's contribute to the depletion of the ozone layer. In the U.S., IVAX currently markets QVAR(R), a CFC-free formulation of beclomethasone dipropionate, the only CFC-free aerosol corticosteroid sold in the United States to treat asthma. While albuterol is a "rescue" medication used to treat asthma attacks, beclomethasone is a "maintenance" medicine used to prevent them. 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. This press release contains certain forward-looking statements regarding product development efforts and product performance and other non-historical facts which are being made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that cannot be predicted or quantified and, consequentially, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, that the FDA may not accept IVAX' NDA or approve this product; that the FDA may not approve IVAX' pending NDA for its standard metered dose inhaler product; 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 share and demand for IVAX' Easi-Breathe inhaler 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. Short Name: IVAX Corporation Category Code: RES Sequence Number: 00009150 Time of Receipt (offset from UTC): 20030829T223814+0100 --30--EG/mi* FLB/ny CONTACT: IVAX Corporation, Miami David Malina, 305-575-6043 KEYWORD: FLORIDA UNITED KINGDOM INTERNATIONAL EUROPE INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL PRODUCT SOURCE: IVAX Corporation Today's News On The Net - Business Wire's full file on the Internet with Hyperlinks to your home page. URL: http://www.businesswire.com
1 Year Innosis Ecological Chart |
1 Month Innosis Ecological Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions