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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  03/18/2016
 
Trade Name:  Anthim
 
Generic Name or Proper Name (*):  obiltoxaximab
 
Indications Studied:  Treatment of inhalational anthrax in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax
 
Label Changes Summary:  * The effectiveness in adults and pediatric patients is based solely on efficacy studies in animal models of inhalational anthrax. * There have been no studies of safety or PK of ANTHIM in the pediatric population. * Information on dosing. * New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Elusys Therapeutics, Inc.
 
NNPS:  FALSE
 
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