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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 | - |
BW20030618002043 20030618T124702Z UTC ( BW)(IVAX-CORPORATION)(IVX) Regulatory Approval Business Editors UK REGULATORY NEWS MIAMI--(BUSINESS WIRE)--June 18, 2003-- IVAX Receives Tentative Approval For Nefazodone HCI Tablets IVAX Corporation (AMEX:IVX) (LSE:IVX.L) announced today that it has received tentative approval from the FDA for its Abbreviated New Drug Application (ANDA) for nefazodone hydrochloride tablets in 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths. Upon final approval, this product will be sold through the company's wholly owned subsidiary, IVAX Pharmaceuticals, Inc. Nefazodone hydrochloride tablets are the generic equivalent of Serzone(R) tablets, marketed by Bristol-Myers Squibb for the treatment of depression. U.S. sales of Serzone for the past twelve months, ending with the first quarter of 2003, were $237 million. 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. 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 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 final approval of IVAX' ANDA for nefazodone hydrochloride tablets in 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg strengths may be delayed or not received at all; that launch of the tablets may be delayed; that the FDA may place restrictions upon or prohibit the sale of the product; that litigation relating to the warnings contained in the product label may impact the sales of this product; 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 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. Serzone(R) is a registered trademark of Bristol-Myers Squibb. Short Name: IVAX Corporation Category Code: REA Sequence Number: 00006078 Time of Receipt (offset from UTC): 20030618T132041+0100 --30--JD/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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