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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:  10/15/2009
Trade Name:  Crestor
Generic Name or Proper Name (*):  rosuvastatin
Indications Studied:  Heterozygous familial hypercholesterolemia
Label Changes Summary:  * New indication in adolescent boys and girls (at least one year post-menarche) 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:  AstraZeneca
Pediatric Exclusivity Granted Date:  07/07/2009
Therapeutic Category:  Antilipemic