TITLE

Gentium Voluntarily Pulls NDA For Defibrotide; Shares Tumble

AUTHOR(S)
Powers, Marie
PUB. DATE
August 2011
SOURCE
BioWorld Today;8/19/2011, Vol. 22 Issue 161, p1
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
This article reports on the voluntary withdrawal by Gentium SpA of its new drug application (NDA) for defibrotide. The company took the move 36 hours after receiving a letter from the Food and Drug Administration ( FDA) which cited a number of issues regarding the NDA for defibrotide. The drug is being investigated for the treatment of hepatic veno-occlusive disease (VOD) in adults and children. Khalid Islam, chair and chief executive officer (CEO) of Gentium, said the company plans to address the issues raised by FDA as quickly as possible.
ACCESSION #
64921755

 

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