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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
Therapeutic Category:  Antilipemic