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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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