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IVAX Receives Final Approval for Doxycycline Hyclate Tablets.


MIAMI -- IVAX Corporation (AMEX:IVX) (LSE:IVX.L) (WSE:IVX) has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for doxycycline doxycycline /doxy·cy·cline/ (dok?se-si´klen) a semisynthetic broad-spectrum tetracycline antibiotic, active against a wide range of gram-positive and gram-negative organisms; used also as d. calcium and d. hyclate.

dox·y·cy·cline (d
 hyclate 20 mg tablets. This product will be sold through IVAX' wholly owned subsidiary, IVAX Pharmaceuticals, Inc. Doxycycline hyclate 20 mg tablets is the generic equivalent of Periostat(R) Tablets, which is marketed by CollaGenex Pharmaceuticals, Inc. for the treatment of bacterial infections and adult periodontitis. According to IMS data, U.S. sales of Periostat(R) Tablets and doxycycline hyclate 20 mg tablets were $51 million during 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 involve risks and uncertainties which may affect the company's business and prospects, including the risks that launch of doxycycline hyclate 20 mg tablets may be delayed or may not occur, and if launched, the products will not be successfully commercialized; changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; the difficulty in predicting the timing and outcome of legal proceedings, including the outcome of CollaGenex Pharmaceuticals, Inc.'s patent infringement claim against IVAX with respect to doxycycline hyclate; that the patent litigation with respect to these products could prevent us from selling these products and could result in substantial damages which could exceed the expected profit or selling price for these products; the difficulty of predicting the timing of U.S. Food and Drug Administration, or FDA, approvals; the impact of FDA's or other administrative or judicial agency's decisions on exclusivity periods; competitors' ability to extend exclusivity periods past initial patent terms; 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. Periostat(R) is a registered trademark of CollaGenex Pharmaceuticals, Inc.
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Publication:Business Wire
Geographic Code:1USA
Date:May 13, 2005
Words:393
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