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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:  10/02/2009
 
Trade Name:  Welchol
 
Generic Name or Proper Name (*):  colesevelam
 
Indications Studied:  Heterozygous familial hypercholesterolemia
 
Label Changes Summary:  * New indication for use as monotherapy or with a statin in boys and postmenarchal girls 10-17 years with heterozygous familial hypercholesterolemia * Has not been studied in children < 10 years or in pre-menarchal girls * Information on dose, adverse events and clinical studies
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Daiichi Sankyo
 
Pediatric Exclusivity Granted Date:  02/17/2009
 
NNPS:  FALSE
 
Therapeutic Category:  Antilipemic
 
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