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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 | - |
IVAX Corporation, Miami David Malina, 305-575-6043 Director/Investor Relations & Corporate Communications IVAX Receives Tentative Approval For Topiramate Tablets IVAX Corporation (AMEX:IVX)(LSE:IVX.L) announced today that it received tentative approval from the FDA for its Abbreviated New Drug Application (ANDA) for Topiramate tablets in 25 mg, 100 mg and 200 mg strengths. Upon final approval, this product will be sold through the company's wholly owned subsidiary, IVAX Pharmaceuticals, Inc. Topiramate is the generic equivalent of Topamax(R), which is marketed by Ortho-McNeil as an anti-epileptic drug to control both partial and grand mal seizures. U.S. sales of Topamax tablets in the 25, 100 and 200 mg dosage strengths were over $785 million for the past twelve month ending in the second quarter of 2003. IVAX continues its aggressive program to increase the number of products in its generic portfolio. 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. The "FDA" refers to the United States Food and Drug Administration. 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 risks that final approval of IVAX' ANDA for topiramate tablets in 25 mg, 100 mg and 200 mg strengths may be delayed or not received at all; that launch of the tablets may be delayed; changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; that IVAX may not file any additional ANDAs; 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. Topamax(R) is a registered trademark of Ortho-McNeil.
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