Business Editors/Health & Medical Writers
MIAMI--(BW HealthWire)--Aug. 9, 2001
IVAX Corporation (AMEX:IVX)(LSE:IVX.L) received approval for its Abbreviated New Drug Application (ANDA) for sales of isosorbide mononitrate extended-release tablets in 30 mg and 120 mg strengths from the United States Food and Drug Administration (FDA). Previously, IVAX received FDA approval for its isosorbide mononitrate extended-release 60 mg tablets. Isosorbide mononitrate is used to treat angina due to coronary artery disease and is the generic equivalent of Schering Corporation's Imdur(R) tablets.
IVAX will sell this product through its wholly owned subsidiary, IVAX Pharmaceuticals, Inc. This marks IVAX' sixth generic drug approval so far this year -- with 33 ANDAs and tentative approvals currently pending at the FDA. The company is continuing its aggressive filing schedule for new ANDA submissions.
IVAX Corporation, headquartered in Miami, Florida, is engaged in the research, development, manufacturing, and marketing of branded and brand equivalent 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, including the statements regarding IVAX' pending ANDAs and tentative approvals and filing schedule for ANDA submissions, involve risks and uncertainties which may affect the company's business and prospects, including the risks that IVAX Pharmaceuticals may not launch isosorbide mononitrate extended-release tablets in 30 mg and 120 mg strengths or that its launch will be delayed; that IVAX may not receive approval of its pending ANDAs or final approval of its tentatively approved ANDAs, or that if approved, the products will not be successfully commercialized; 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 2000 Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission. Imdur(R) is a registered trademark of Schering Corporation.
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COPYRIGHT 2001 Gale Group
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