Akzo Nobel: Arixtra Approved by the FDA in the United States.Business Editors & Health/Medical Writers ARNHEM/OSS, The Netherlands--(BUSINESS WIRE)--Dec. 10, 2001 Akzo Nobel's 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 announced today that Arixtra (fondaparinux sodium fondaparinux sodium Arixtra Pharmacologic class: Selective factor Xa inhibitor Therapeutic class: Anticoagulant, antithrombotic Pregnancy risk category B FDA Boxed Warning) has been approved in the United States by the Food and Drug Administration (FDA FDAabbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). Arixtra is indicated for the prophylaxis of deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen. , which may lead to pulmonary embolism, in patients undergoing hip fracture surgery, hip replacement surgery, and knee replacement surgery. The New Drug Application for Arixtra was submitted in the United States in February 2001, and was granted a six-month priority review. In August, Arixtra was granted an "Approvable Letter" by the FDA. Arixtra is currently under review in the European Union, where the file was also submitted in February 2001. Organon and Sanofi-Synthelabo expect to establish a strong position in the antithrombotic field with this new drug. Further clinical investigations are being carried out to extend Arixtra's use. Arixtra is a synthetic compound and the first in a new class of antithrombotic agents that selectively inhibit Factor Xa. Arixtra was discovered and is being co-developed by Organon and Sanofi-Synthelabo. The launch of Arixtra in the United States will occur in the first quarter of 2002. Note for the editor 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 67,400 people in 80 countries. Financial results for the full year 2001 will be published on February 22, 2002. Organon is a renowned global pharmaceutical company with a strong commitment to health care. The company develops and produces innovative prescription medicines for gynecology, psychiatry, cardiovascular disease, immunology and anesthesiology. 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. NV Organon is the ethical pharmaceutical business unit of Akzo Nobel. Internet: -- http://www.akzonobel.com -- http://www.organon.com Note to Editors: This press release is also accessible online at www.Waymaker.net. |
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