» Business Wire - IVAX Receives Final Approval For Fluconazole Tablets

Business Wire - IVAX Receives Final Approval For Fluconazole Tablets

MIAMI — IVAX Corporation (AMEX:IVX) (LSE:IVX.L) received final approval for its Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for fluconazole tablets in 50, 100, 150, and 200 mg dosage strengths. Fluconazole is the generic equivalent of Diflucan(R), an antifungal agent marketed by Pfizer to treat yeast infections. U.S. sales for fluconazole tablets were $475 million during 2003. The product will be sold through IVAX’ wholly owned subsidiary, IVAX Pharmaceuticals, Inc.
IVAX continues its aggressive program to increase the number of products in its generic portfolio.

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EXECUTIVE SUMMARY

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 fluconazole tablets in 50mg, 100mg, 150mg and 200mg strengths 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’ aggressive program to increase the number of products in its generic portfolio may not be successful; 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. Diflucan(R) is a registered trademark of Pfizer.
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