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IVAX Receives Final Approval on Citalopram Hydrobromide Tablets
Business Wire, Nov 17, 2004
MIAMI -- IVAX Corporation (AMEX:IVX) (LSE:IVX.L) received final approval from the Federal Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for citalopram hydrobromide tablets in 10, 20, and 40 mg dosages. Citalopram is the generic equivalent of Celexa(R), which is marketed by Forest Pharmaceuticals for the treatment of depression. According to IMS data, U.S. sales of Celexa 10, 20 and 40 mg tablets were over $1.4 billion for the year ending June 30, 2004. This product will be marketed by IVAX' wholly-owned subsidiary, IVAX Pharmaceuticals Inc.
IVAX continues its aggressive program to increase the number of products in its generic portfolio.
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, including the statements regarding IVAX' generic portfolio, involve risks and uncertainties which may affect the company's business and prospects, including the risks that the launch of citalopram tablets in 10mg, 20mg and 40mg strengths may be delayed; changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; that IVAX' aggressive program to increase the number of products in its generic portfolio may not be successful; 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 Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission. Celexa(R) is a registered trademark of Forest Pharmaceuticals.
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