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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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BW20030429002178 20030429T172048Z UTC ( BW)(IVAX-CORPORATION)(IVX) IVAX Confirms First To File Status On Gabapentin Tablets In Certain Dosage Strengths; Responds To Inquiries Following Recent Alpharma/Apotex Court Decision Business Editors UK REGULATORY NEWS MIAMI--(BUSINESS WIRE)--April 29, 2003-- IVAX Corporation (AMEX:IVX) (LSE:IVX.L), in response to inquiries, today confirmed that it believes that it has first to file status on gabapentin tablets in 100 mg, 300 mg and 400 mg dosage strengths. Gabapentin is the active ingredient in Neurontin(R) which is marketed by Warner-Lambert, a unit of Pfizer Inc. Monday's decision by the U.S. District Court for the District of Columbia upholding the FDA's decision that Alpharma, and not Apotex, was the first to challenge Pfizer's patent does not impact the status of IVAX' ANDA or its ability to launch. Neurontin is marketed by Warner-Lambert in 5 dosage strengths, 100 mg, 300 mg and 400 mg capsules, and 600 mg and 800 mg tablets. IVAX has amended a previously filed ANDA to include tablets in 100 mg, 300 mg and 400 mg dosage strengths and believes that it has first to file status on gabapentin tablets in these strengths. Tablets in these strengths are not currently marketed and, upon approval, IVAX plans to market them to HMOs and other institutional purchasers as Gabaron(TM), a lower priced brand alternative. IVAX also has ANDAs pending for the 100 mg, 300 mg and 400 mg capsules, and 600 mg and 800 mg tablets currently marketed by Warner-Lambert, and was previously notified by the FDA that its ANDA for the 100 mg, 300 mg and 400 mg capsules is approvable. Upon receiving final approval IVAX will market these dosages as generic equivalents through its subsidiary, IVAX Pharmaceuticals, Inc. IVAX has 38 ANDAs pending at the FDA. The company is continuing 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 IVAX Pharmaceuticals may not receive final approval for gabapentin tablets or capsules in any or all of the strengths or that its launch will be delayed; that IVAX may not have first to file status; the impact of FDA's or other administrative or judicial agency's decisions on exclusivity periods; that IVAX may not receive approval of its pending ANDAs, or that if approved, the products will not be successfully commercialized; 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. Neurontin(R) is a registered trademark of Warner-Lambert Company, a unit of Pfizer Inc. Short Name: IVAX Corporation Category Code: MSC Sequence Number: 00004395 Time of Receipt (offset from UTC): 20030429T175626+0100 --30--CP/mi* sm/uk* CONTACT: IVAX Corporation, Miami Jim Whitlow, 305/575-6043 KEYWORD: FLORIDA UNITED KINGDOM INTERNATIONAL EUROPE INDUSTRY KEYWORD: 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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