IVAX Corporation (AMEX:IVX) received approval for the company's Abbreviated New Drug Application (ANDA) for fluvoxamine maleate tablets in 25 mg, 50 mg and 100 mg strengths from the United States Food and Drug Administration (FDA). Indicated for the treatment of obsessive compulsive disorder (OCD), fluvoxamine maleate tablets are the generic equivalent of Solvay Pharmaceuticals' Luvox(R) tablets, which had 2000 U.S. sales of approximately $190 million. IVAX will market the product through its U.S. generic subsidiary, IVAX Pharmaceuticals, Inc.
IVAX has received three generic approvals so far this year, and has 36 additional ANDAs pending at the FDA. The company anticipates continuing an aggressive filing schedule for new ANDA submissions during 2001.
IVAX Corporation, headquartered in Miami, Florida, is a holding company with subsidiaries engaged in the research, development, manufacturing, and marketing of branded and generic pharmaceuticals and veterinary and diagnostic products in the U.S. and international markets.
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 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 IVAX Pharmaceuticals may not launch fluvoxamine maleate tablets or that its launch will be delayed; that IVAX may not receive approval of its pending ANDAs; that IVAX may not file additional ANDAs during 2001; and other risks and uncertainties based on economic, competitive, governmental, technological and other factors discussed in the Company's 1999 annual report on form 10-KA and its other filings with the Securities and Exchange Commission. Luvox(R) is a registered trademark of Solvay Pharmaceuticals, Inc.