Published in Drug Week, June 30th, 2006
The U.S. Food and Drug Administration (FDA) has reviewed the protocol for this study under the Special Protocol Assessment (SPA) process. Previous phase III trials for Sanvar in this indication were conducted in Europe.
EVB is a frequent complication of late stage liver cirrhosis that affects approximately 750,000 patients per year worldwide. Survival is directly related to effective, early control of the bleeding episode, with one in...
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