Business Services Industry
IVAX To Begin Selling Tramadol
Business Wire, July 5, 2002
Business Editors/Health & Medical Writers
IVAX Corporation (AMEX:IVX) (LSE:IVX.L) announced today that it will immediately begin selling tramadol hydrochloride 50 mg tablets through its wholly owned subsidiary, IVAX Pharmaceuticals, Inc., now that FDA approval of the Abbreviated New Drug Application (ANDA) for this product has been received. Tramadol is used to treat persistent moderate to severe pain and is the generic equivalent of Ultram(R) tablets marketed by Johnson & Johnson. Annual U.S. sales of Ultram are approximately $550 million.
IVAX currently has 35 ANDAs and one tentative approval pending at the FDA. The company is continuing its aggressive filing schedule for new ANDA submissions.
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' web site at http://www.ivax.com. Shareholders and prospective investors can register to automatically receive the company's press releases via email at www.ivax.com/ComNewsv2.htm.
The "FDA" refers to the United States Food and Drug Administration.
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' 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 the launch of tramadol hydrochloride tablets in 50 mg strength will be delayed; that the compounds and products in the IVAX' research pipeline will not be successfully developed, will not receive regulatory approval or 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; 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 2001 Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission. Ultram(R) Tablets is a registered trademark of Johnson & Johnson.
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