U.S. Food and Drug Administration approves Arixtra for extended use

Report this content

U.S. Food and Drug Administration approves Arixtra® for extended use Arnhem, the Netherlands, June 18, 2003 - Akzo Nobel's human pharmaceutical business unit Organon announced today that Organon Sanofi- Synthélabo LLC received approval from the U.S. Food and Drug Administration (FDA) for a supplemental new drug application (sNDA) for Arixtra® (fondaparinux sodium), for: "Prophylaxis of deep venous thrombosis, which may lead to pulmonary embolism, in patients undergoing hip fracture surgery, including extended prophylaxis." The usual duration of Arixtra therapy is five-to-nine days. With the new indication, which was approved under priority review, an additional 24 days of Arixtra treatment will be recommended in patients at risk for deep vein thrombosis. - - - Note for the editor Akzo Nobel, based in the Netherlands, serves customers throughout the world with healthcare products, coatings and chemicals. Consolidated sales for 2002 totaled EUR 14 billion. The Company currently employs approximately 67,500 people in more than 80 countries. Financial results for the second quarter will be published on July 18, 2003. Internet: www.akzonobel.com Not for publication - for more information Akzo Nobel N.V. Corporate Media Relations, tel. +31 26 366 4343 Organon - Sanofi-Synthélabo LLC, Fran DeSena, Director Communications and Media Relations, tel. +1 973 325 5353 Safe Harbor Statement* This press release contains statements, which address such key issues as Akzo Nobel's growth strategy, future financial results, market positions, product development, pharmaceutical products in the pipeline, and product approvals. Such statements should be carefully considered and it should be understood that many factors could cause forecasted and actual results to differ from these statements. These factors include, but are not limited to price fluctuations, currency fluctuations, developments in raw material and personnel costs, physical and environmental risks, legal issues, and legislative, fiscal, and other regulatory measures. Stated competitive positions are based on management estimates supported by information provided by specialized external agencies. For a more complete discussion of the risk factors affecting our business please refer to our Annual Report on Form 20-F filed with the United States Securities and Exchange Commission. * Pursuant to the U.S. Private Securities Litigation Reform Act 1995. Akzo Nobel nv Velperweg 76 P.O. Box 9300 6800 SB Arnhem The Netherlands Tel +31 26 366 43 43 Fax +31 26 366 49 40 ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.waymaker.net/bitonline/2003/06/19/20030619BIT00280/wkr0001.doc http://www.waymaker.net/bitonline/2003/06/19/20030619BIT00280/wkr0002.pdf