Gentium Announces NDA Submission for Defibrotide

August 2011
Worldwide Biotech;Aug2011, Vol. 23 Issue 8, p2
Trade Publication
The article reports on a new drug application (NDA) submitted by Gentium SpA to the U.S. Food and Drug Administration (FDA) for Defibrotide for the treatment of hepatic veno-occlusive disease (VOD) in patients undergoing hematopoietic stem-cell transplantation (HSCT). The drug has allegedly been tested in over 250 clinics in 33 nations and is ready for Phase 3 studies throughout the U.S. pending FDA approval. Information on data supporting the efficacy of Defibrotide to treat hepatic VOD in HSCT patients is offered.


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