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IVAX Receives Final Approval for Doxazosin Mesylate Tablets.


Business Editors/Medical Writers

MIAMI--(BUSINESS WIRE)--Oct. 19, 2000

IVAX Corporation (AMEX:IVX) received final approval for the company's Abbreviated New Drug Application (ANDA) for doxazosin doxazosin /dox·a·zo·sin/ (dok-sa´zo-sin) a compound that blocks a; used as d. mesylate mesylate /mes·y·late/ (mes´i-lat) USAN contraction for methanesulfonate.

mes·y·late (ms
in the treatment of hypertension and of benign prostatic hyperplasia.
 mesylate in 1 mg, 2 mg, 4 mg, and 8 mg tablet strengths from the United States Food and Drug Administration (FDA). Indicated for benign prostatic hyperplasia (BPH) and hypertension, doxazosin mesylate dox·a·zo·sin mesylate (dk-sz-s tablets are the generic equivalent of Pfizer's Cardura Car·dur·a (kär-dr)
A trademark for the drug doxazosin mesylate.
(R), which had sales of approximately $313 million in the U.S. in 1999. IVAX will immediately begin marketing and shipping the product through its wholly owned subsidiary, Zenith Goldline Pharmaceuticals, Inc.

"With the final approval of doxazosin mesylate, Zenith Goldline has received nine final and two tentative approvals so far this year, with 27 additional ANDAs pending at the FDA," said Dr. Rafick Henein, president and chief executive officer of Zenith Goldline Pharmaceuticals. "We expect to file 17 additional ANDAs during the remainder of the year."

IVAX Corporation, headquartered in Miami, Fla., 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 that may affect IVAX' business and prospects, including the risks that Pfizer or others may assert patent rights against the product after it is launched; that the product will not achieve any significant level of sales; that the company's other pending ANDAs will not be approved; that additional ANDA filings will not be made as scheduled, or at all; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. In addition to the risk factors set forth above, investors should consider the economic, competitive, governmental, technological and other factors discussed in the Company's Annual Report on form 10KA and other filings with the Securities and Exchange Commission. Cardura(R) is a registered trademark of Pfizer Inc.
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Publication:Business Wire
Geographic Code:1USA
Date:Oct 19, 2000
Words:358
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