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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:  04/10/2006
 
Trade Name:  Lescol & Lescol XL
 
Generic Name or Proper Name (*):  fluvastatin
 
Indications Studied:  Heterozygous familial hypercholesterolemia as an adjunct to diet
 
Label Changes Summary:  * New indication in adolescent boys and girls (at least one year post-menarche) 10-16 years of age, with heterozygous familial hypercholesterolemia * Information on dose, AE profile and clinical studies
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Novartis
 
Pediatric Exclusivity Granted Date:  12/15/2005
 
NNPS:  FALSE
 
Therapeutic Category:  Antilipemic
 
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