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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:  12/05/2008
 
Trade Name:  Arimidex
 
Generic Name or Proper Name (*):  anastrozole
 
Indications Studied:  Male pubertal patients with gynecomastia and female pediatric patients with McCune-Albright syndrome with progressive precocious puberty
 
Label Changes Summary:  * Efficacy has not been demonstrated in clinical studies of anastrozole in the treatment of pubertal gynecomastia in adolescent boys 11-18 years and in the treatment of precocious puberty in girls with McCune-Albright Syndrome 2 to < 10 years * Information on clinical studies, AEs, and PK parameters
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  AstraZeneca
 
Pediatric Exclusivity Granted Date:  11/14/2007
 
NNPS:  FALSE
 
Therapeutic Category:  Estrogen lowering agent
 
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