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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
Sponsor:
AstraZeneca
Pediatric Exclusivity Granted Date:
11/14/2007
NNPS:
FALSE'
Therapeutic Category:
Estrogen lowering agent
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