Akzo Nobel's Arixtra Drug Receives ``Approvable Letter'' from FDA.Business Editors & Health Writers ARNHEM, the Netherlands--(BUSINESS WIRE)--Aug. 16, 2001 Akzo Nobel's (NasdaqNM:AKZOY) business unit Organon or·ga·non or or·ga·num n. pl. or·ga·nons or or·ga·nums or or·ga·na 1. An organ. 2. A set of principles for use in scientific investigation. organon pl. organa [Gr.] organ. and Sanofi-Synthelabo have received an "approvable letter" from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for their new antithrombotic drug Arixtra(R) (fondaparinux sodium). This opens the door for final approval for Arixtra in the United States for the prevention of venous thromboembolic thromboembolic pertaining to or emanating from thromboembolism. thromboembolic meningoencephalitis see hemophilosis. thromboembolic parasitism see thromboembolic colic. events following major orthopedic surgery. The New Drug Application for fondaparinux sodium, the active compound in Arixtra, was submitted on February 15, 2001 in both the United States and Europe. The FDA granted Arixtra a six-month priority review, a status reserved for drugs that show clear potential for the treatment of serious or life-threatening conditions that cannot be provided by existing therapies. Organon and Sanofi-Synthelabo expect to establish a strong position in the antithrombotic field with this new drug. Advanced clinical trials are being carried out to extend Arixtra's use for the treatment of venous thrombosis and pulmonary embolism (phase III) and for treatment of arterial thrombosis (phase IIB IIB Institute for Independent Business IIB Institute of International Business IIB Institute of International Bankers IIB International Investment Bank IIB Indian Institute of Banking & Finance IIB Included in Bankruptcy IIB Ice, Ice, Baby ). Arixtra (fondaparinux sodium) was discovered and is being co-developed by Organon and Sanofi-Synthelabo (France). N.V. Organon is a renowned global pharmaceutical company with a strong commitment to healthcare. The company develops and produces innovative prescription medicines for gynecology, psychiatry, cardiovascular disease and immunology. Organon products are sold in over 100 countries, more than half of which have an Organon subsidiary. The company currently employs around 12,500 people. Akzo Nobel, based in the Netherlands, serves customers throughout the world with healthcare products, coatings and chemicals. Consolidated sales for 2000 totaled EUR EUR In currencies, this is the abbreviation for the Euro. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. 14 billion (USD USD In currencies, this is the abbreviation for the U.S. Dollar. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. 13 billion, GBP GBP In currencies, this is the abbreviation for the British Pound. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. 8.5 billion). The Company currently employs 67,500 people in more than 75 countries. Financial results for the third quarter of 2001 will be published on October 24, 2001. Note to Editors: This press release is also accessible online at www.Waymaker.net, www.organon.com, www.akzonobel.com. The following files are available for download: http://www.waymaker.net/bitonline/2001/08/16/20010816BIT00650/bit0002.doc http://www.waymaker.net/bitonline/2001/08/16/20010816BIT00650/bit0002.pdf |
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