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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 David Malina, 305/575-6043 IVAX Responds To First To File Reports On Metformin ER In response to reports citing that IVAX Corporation (AMEX:IVX) (LSE:IVX.L) will receive "first to file" status from the FDA for Metformin ER, the generic equivalent of Bristol-Myers Squibb's Glucophage XR(R), IVAX' Vice Chairman and President, Neil Flanzraich said, "The FDA doesn't announce 'first to file' standing prior to awarding a company final approval for a generic; however, if we were to receive 'first to file' position on Metformin ER, it is a product, like others in our pipeline, that will make a significant contribution to IVAX' earnings." 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 involve risks and uncertainties which may affect the company's business and prospects including the risks that IVAX may not be the first to file on metformin ER; that regulatory approval for metformin ER may be delayed or not received or that the product may not be successfully commercialized; that metformin ER may not make a significant contribution to IVAX' earnings even if it receives first to file status; that exclusivity periods and the launch of metformin ER may be challenged by third parties, including challenges regarding patent infringement; the difficulty in predicting the timing of FDA approvals and the FDA's or other administrative or judicial agency's decisions on exclusivity periods; 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 receive approval of its pending ANDAs, or that if approved, the products will not be successfully commercialized; that the compounds and products in IVAX' generic pipeline will not be successfully developed, will not receive regulatory approval or will not be successfully commercialized 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. Glucophage XR(R) is a registered trademark of Bristol-Myers Squibb Company.
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