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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
 
NNPS:  FALSE'
 
Therapeutic Category:  Antilipemic
 
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