Business Services Industry
IVAX Receives Final Approval for Fluticasone Nasal Spray In UK
Business Wire, May 13, 2005
MIAMI -- IVAX Corporation (AMEX:IVX) (LSE:IVX.L) (WSE:IVX) received final Marking Authorization approval from the Medicine and Healthcare Products Regulatory Agency for fluticasone nasal spray. Fluticasone is the generic equivalent of Flixonase(R) (known in the U.S. as Flonase(R)) and marketed by GlaxoSmithKline for the treatment of rhinitis. IVAX' generic equivalent of this product has been developed for the UK by IVAX Research Inc. in the United States and is part of a worldwide development program. This is the first generic approval for fluticasone in the UK and IVAX will be marketing this product immediately. Annual UK sales of Flixonase are approximately $30 million. IVAX expects to pursue further approvals for this product across Europe, and has an ANDA for a generic equivalent of Flonase pending with the U.S. Food and Drug Administration.
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 fluticasone nasal spray in the U.K. may be delayed; that IVAX may not receive further approvals for this product in Europe; that IVAX may not receive approval of its pending ANDA for fluticasone in the U.S. and if it is approved may not successfully market the product; changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; 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. Flixonase(R) and Flonase(R) are registered trademarks of GlaxoSmithKline.
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