Approvable??? Without explanation!
What is wrong? Safety?
Thursday August 16, 6:34 am Eastern Time
Press Release
SOURCE: Akzo Nobel
Akzo Nobel's Arixtra Drug Receives ``Approvable Letter'' from FDA
ARNHEM, the Netherlands--(BUSINESS WIRE)--Aug. 16, 2001--Akzo Nobel's (NasdaqNM:AKZOY) business unit Organon and Sanofi-Synthélabo have received an ``approvable letter'' from the U.S. Food and Drug Administration (FDA) for their new antithrombotic drug Arixtra® (fondaparinux sodium). This opens the door for final approval for Arixtra in the United States for the prevention of venous thromboembolic 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-Synthélabo 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).
Arixtra (fondaparinux sodium) was discovered and is being co-developed by Organon and Sanofi-Synthélabo (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 14 billion (USD 13 billion, GBP 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.
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