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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:  08/30/2002
 
Trade Name:  Nolvadex
 
Generic Name or Proper Name (*):  tamoxifen
 
Indications Studied:  McCune-Albright Syndrome
 
Label Changes Summary:  * A study in 28 female patients aged 2-10 years with McCune-Albright Syndrome and precocious puberty did not demonstrate safety and effectiveness. Long term effects have not been established * Mean uterine volume increased after 6 months of therapy and doubled at end of 1-year study
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  AstraZeneca
 
Pediatric Exclusivity Granted Date:  05/16/2002
 
NNPS:  FALSE
 
Therapeutic Category:  Hormone
 
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