Business Services Industry
IVAX Receives FDA Approvals for Two Brand Equivalent Products
Business Wire, July 1, 2002
Business Editors/Health & Medical Writers
IVAX Corporation (AMEX:IVX) (LSE:IVX.L) announced it has received final FDA approvals for its Abbreviated New Drug Applications (ANDA's) for its lisinopril tablets in 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg strengths and its lisinopril/HCTZ (hydrochlorothizide) tablets in 10 mg, 20/12.5 mg and 20/25 mg strengths. The company's wholly owned subsidiary, IVAX Pharmaceuticals, Inc., will immediately begin shipping these products. Lisinopril and lisinopril/HCTZ are used to treat hypertension, heart failure and acute myocardial infarction and are the generic equivalent of Zestril(R) and Zestoretic(R) tablets sold by AstraZeneca and of Prinivil(R) and Prinzide(R) tablets sold by Merck & Company. Annual U.S. sales of these products are approximately $2.1 billion.
Related Results
IVAX now 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 http://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 lisinopril tablets in 2.5 mg, 5 mg, 10 mg, 20 mg 30 mg and 40 mg strengths or lisinopril/HCTZ tablets in 10 mg, 20/12.5 mg and 20/25 mg strengths 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. Zestril(R) and Zestoretic(R) tablets are registered trademarks of AstraZeneca. Prinivil(R) and Prinzide(R) tablets are registered trademarks of Merck & Company.
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