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www.fdanews.com/articles/138155-gentium-announces-nda-submission-for-defibrotide

Gentium Announces NDA Submission for Defibrotide

July 6, 2011
Gentium announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration for Defibrotide for the treatment of hepatic veno-occlusive disease (VOD) in adults and children undergoing hematopoietic stem-cell transplantation (HSCT).
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