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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:  12/19/2008
 
Trade Name:  Casodex
 
Generic Name or Proper Name (*):  bicalutamide
 
Indications Studied:  Gonadotropin-independent precocious puberty in boys with familial male-limited precocious puberty (testotoxicosis)
 
Label Changes Summary:  Safety and effectiveness have not been established in pediatric patients Bicalutamide was studied in combination with anastrozole in an open-label, non-comparative, multi-center study that assessed the efficacy and safety of this combination regimen over 12 months in the treatment of testotoxicosis in patients e2 years Of the 14 patients exposed to study treatment, 13 had at least one adverse event. Adverse reactions considered possibly related to bicalutamide included gynecomastia (43%), central precocious puberty (14%), breast tenderness (14%), breast pain (7%), asthenia (7%), increased alanine aminotransferase (7%), increased aspartate aminotransferase (7%), and musculoskeletal chest pain (7%). Headache was the only adverse reaction considered possibly related to anastrozole Information on clinical studies, AEs, and PK parameters
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  AstraZeneca
 
Pediatric Exclusivity Granted Date:  09/19/2008
 
NNPS:  FALSE'
 
Therapeutic Category:  Androgen blocker
 
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