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Share Name | Share Symbol | Market | Type |
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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 | |
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0.00 | 0.00% | 0.00 | - |
BW20030801000321 20030801T125626Z UTC ( BW)(IVAX-CORPORATION)(IVX) Regulatory Approval Business Editors UK REGULATORY NEWS LONDON--(BUSINESS WIRE)--Aug. 1, 2003-- IVAX Receives Approval On Clozapine 12.5 Mg Tablets IVAX Corporation (AMEX:IVX) (LSE:IVX.L) announced today that its wholly owned subsidiary, IVAX Pharmaceuticals, Inc., has received final FDA approval for its Abbreviated New Drug Application (ANDA) for clozapine in a 12.5 mg tablet dosage. Clozapine is the generic equivalent of Clozaril(R) which is marketed by Novartis and used in the treatment of schizophrenia. U.S. sales for Clozaril and its generic equivalent, clozapine, were $207.7 million for the past twelve months, ending March 31, 2003. IVAX currently has a market share of 43.4% of the total (Clozaril and clozapine combined) market's extended units. The drug is sold in 100 mg and 25 mg tablet dosage strengths. IVAX' 12.5 mg tablet is a new dosage strength developed by IVAX to facilitate dose titration and minimize the risk of side effects. IVAX will manufacture the clozapine 12.5 mg tablets at its subsidiary in Cidra, Puerto Rico and expects to market the tablets in 30 days. IVAX currently has 39 ANDAs pending at the FDA. The company continues its aggressive filing schedule for new ANDA submissions. 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 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, including the statements regarding IVAX' pending ANDAs and filing schedule for ANDA submissions, involve risks and uncertainties which may affect the company's business and prospects, including the risks that the launch of clozapine in 12.5 mg strengths will be delayed; that this product may not prove to have the perceived advantages or reduced side effects over the other available dosage strengths; changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; and other risks and uncertainties based on economic, competitive, governmental, technological and other factors discussed in the Company's Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission. Clozaril(R) is a registered trademark of Novartis. Short Name: IVAX Corporation Category Code: REA Sequence Number: 00007888 Time of Receipt (offset from UTC): 20030801T133248+0100 --30--CP/mi* KO/uk CONTACT: IVAX Corporation KEYWORD: UNITED KINGDOM INTERNATIONAL EUROPE INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL 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
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