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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 | - |
BW20030801002041 20030801T153936Z UTC ( BW)(IVAX-CORPORATION)(IVX) Regulatory Approval Business Editors UK REGULATORY NEWS LONDON--(BUSINESS WIRE)--Aug. 1, 2003-- IVAX Receives Tentative Approval For Pravastatin Sodium 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 pravastatin sodium tablets in 10 mg, 20 mg and 40 mg dosage strengths. Upon final approval, this product will be sold through the company's wholly owned subsidiary, IVAX Pharmaceuticals, Inc. Pravastatin sodium is the generic equivalent of Pravachol(R), which is marketed by the Bristol-Myers Squibb Company and is prescribed for people with high cholesterol or heart disease. U.S. sales of Pravachol tablets, in 10 mg, 20 mg and 40 mg strengths, were $1.75 billion for the past twelve months, ending March 31, 2003. 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 final approval of IVAX' ANDA for pravastatin sodium tablets in 10 mg, 20 mg and 40 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 receive approval of its pending ANDAs, or that if approved, the products 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. Pravachol(R) is a registered trademark of Bristol-Myers Squibb. Short Name: IVAX Corporation Category Code: REA Sequence Number: 00007909 Time of Receipt (offset from UTC): 20030801T161922+0100 --30--GAA/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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