Tokyo, Japan, Nov 25, 2005 - (JCNN) - GlaxoSmithKline (GSK) announced on November 24 that it has submitted a New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare, seeking marketing approval of fondapariux sodium. Fondapariux sodium is a selective inhibitor of Factor Xa, a protein central to the coagulation process.
The company is seeking an indication for venous thromboembolism in patients undergoing orthopedic procedures.
Initially approved in the US in December 2001, the agent is currently marketed in 30 countries worldwide under the trade name of Arixtra.
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