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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 IVAX Corporation (AMEX:IVX) (LSE:IVX.L) has received tentative approval from the FDA for its Abbreviated New Drug Application (ANDA) for gabapentin capsules in 100 mg, 300 mg and 400 mg strengths. Upon final approval this product will be sold through the company's wholly owned subsidiary, IVAX Pharmaceuticals, Inc. Gabapentin is the generic equivalent of Neurontin(R), which is used to treat epileptic seizures and is marketed by Warner-Lambert, a unit of Pfizer, Inc. Neurontin had U.S. sales of over $2.2 billion during the twelve months ending in June 2003. Warner-Lambert sells Neurontin in 5 dosage strengths, 100 mg, 300 mg and 400 mg capsules and 600 mg and 800 mg tablets. IVAX has also filed an ANDA for gabapentin tablets in 100 mg, 300 mg, 400 mg, 600 mg and 800 mg dosage strengths and believes that it has first to file status on gabapentin tablets in 100 mg, 300 mg and 400 mg strengths. 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 involve risks and uncertainties which may affect the company's business and prospects, including the risks that final approval of IVAX' ANDA for gabapentin capsules in 100 mg, 300 mg and 400 mg dosage strengths may be delayed or not received at all; that launch of the capsules 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; the difficulty in predicting the timing and outcome of legal proceedings, including those relating to patent challenge settlements and patent infringement cases; the difficulty of predicting the timing of U.S. Food and Drug Administration, or FDA, approvals; the impact of FDA's or other administrative or judicial agency's decisions on exclusivity periods; competitors' ability to extend exclusivity periods past initial patent terms; that IVAX may not receive approval of its pending ANDA for the 100 mg, 300 mg, 400 mg, 600 mg and 800 mg tablets, or that if approved, the products will not be successfully commercialized; that IVAX may not be first to file for the 100 mg, 300 mg, 400 mg tablets; that market acceptance for the tablet dosage form of gabapentin may not be as anticipated; that IVAX may not increase the number of products in its generic portfolio; 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.
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