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DewDiligence

10/26/15 6:27 PM

#196418 RE: DewDiligence #196268

Updated FDA label for V-Pak (as of 10/22/15):

http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206619s008lbl.pdf

The main change is in section 5.1 of the label, which addresses “Risk of Hepatic Decompensation and Hepatic Failure in Patients with Cirrhosis.” The new language is indicated by vertical bars.