MIAMI -- IVAX Corporation (AMEX:IVX) (LSE:IVX.L) (WSE:IVX) has received a final approval from the U.S. Drug and Food Administration (FDA) for its Abbreviated New Drug Application (ANDA) for cilostazol tablets, 100 mg. This product will be sold through the company's wholly owned subsidiary, IVAX Pharmaceuticals, Inc. Cilostazol tablets, 100 mg is the generic equivalent of Pletal(R) Tablets, which is marketed by Otsuka American Pharmaceutical, Inc. for intermittent claudication (pain in the legs that happens when walking and goes away with rest). According to IMS data, U.S. sales of cilostazol tablets, 100 mg were $154.2 million for 2004.
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' generic portfolio, involve risks and uncertainties which may affect the company's business and prospects, including the risks that the launch of cilostazol tablets in 100 mg strength 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; 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. Pletal(R) is a registered trademark of Otsuka Pharmaceutical Company, Ltd.
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