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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:  10/18/2002
Trade Name:  Zocor
Generic Name or Proper Name (*):  simvastatin
Indications Studied:  Heterozygous Familial Hypercholesterolemia
Label Changes Summary:  * New indication in adolescent boys and girls (at least one year post-menarche) 10-17 years of age
Product Labeling:  Labeling  Opens a new window
Sponsor:  Merck
Pediatric Exclusivity Granted Date:  02/22/2002
Therapeutic Category:  Antilipemic