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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:  06/05/2008
 
Trade Name:  Zetia and Vytorin
 
Generic Name or Proper Name (*):  ezetimibe and ezetimibe/ simvastatin
 
Indications Studied:  Heterozygous familial hypercholesterolemia as an adjunct to diet
 
Label Changes Summary:  The effects of ezetimibe co-administered with simvastatin compared to simvastatin monotherapy have been evaluated in adolescent boys and girls with heterozygous familial hypercholesterolemia (HeFH)
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  MSP Singapore
 
Pediatric Exclusivity Granted Date:  02/14/2008
 
NNPS:  FALSE'
 
Therapeutic Category:  Antilipemic
 
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