FDA Grants Priority Review to ARIXTRA(R) (Fondaparinux Sodium), for the Prevention of Venous Thrombo-Embolic Events Following Orthopedic Surgery

Apr 26, 2001, 01:00 ET from Sanofi-Synthelabo

    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(R) (fondaparinux
 sodium), a synthetic pentasaccharide, for the prevention of venous thrombo-
 embolic events following orthopedic surgery.  The New Drug Application (NDA)
 for ARIXTRA(R) 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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SOURCE Sanofi-Synthelabo
    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(R) (fondaparinux
 sodium), a synthetic pentasaccharide, for the prevention of venous thrombo-
 embolic events following orthopedic surgery.  The New Drug Application (NDA)
 for ARIXTRA(R) 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.
 
                     MAKE YOUR OPINION COUNT -- Click Here
                http://tbutton.prnewswire.com/prn/11690X41141207
 
 SOURCE  Sanofi-Synthelabo