TITLE

Xolair anaphylaxis risk added to label

PUB. DATE
July 2007
SOURCE
Drug Topics;7/23/2007, Vol. 151 Issue 14, p6
SOURCE TYPE
Trade Publication
DOC. TYPE
Article
ABSTRACT
The article reports on changes to the label of anaphylaxis drug omalizumab, marketed as Xolair, from Genentech Inc. The company has added a boxed warning label and modified the Warnings, Precautions and Adverse Reactions sections of the prescribing information to indicate the risk of anaphylaxis following administration of the asthma therapy. It is suggested that omalizumab should be administered to patients only in a healthcare setting under direct medical supervision. The drug is approved to treat adults and adolescents with moderate to severe persistent asthma.
ACCESSION #
26131608

 

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