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Biotech / Medical : CVAS-an interesting california-based biotech company here

CVAS 0.000400

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Oct 7 9:32 AM EST

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To: Miljenko Zuanic who wrote (33)	4/26/2001 6:52:28 PM
From: Miljenko Zuanic	Read Replies (1) of 126

Other side is doing well. Thursday April 26, 9:53 am Eastern Time Press Release SOURCE: Sanofi-Synthelabo and Organon FDA Grants Priority Review to ARIXTRA(R) (Fondaparinux Sodium), for the Prevention of Venous Thrombo-Embolic Events Following Orthopedic Surgery PARIS, April 26 /PRNewswire/ -- Sanofi-Synthelabo and Organon announced today that the U.S. Food and Drug Administration (FDA) has granted a six-month priority review -- ``fast track'' review -- for ARIXTRA® (fondaparinux sodium), a synthetic pentasaccharide, for the prevention of venous thrombo- embolic events following orthopedic surgery. The New Drug Application (NDA) for ARIXTRA® had been submitted on February 15, 2001 in the United States. A drug designated as a ``fast track'' product is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address unmet medical needs. Fondaparinux sodium is currently under review for the same indication in Europe, where the dossier has also been submitted on February 15, 2001. It is also in phase III for the treatment of venous thrombo-embolic disease and in phase IIb for the treatment of arterial thrombo-embolic disease. This entirely synthetic compound was discovered and is being co-developed by Sanofi-Synthelabo and Organon.

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