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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:  08/29/2012
 
Trade Name:  Afinitor Disperz
 
Generic Name or Proper Name (*):  everolimus
 
Indications Studied:  Treatment of subependymal giant cell astrocytoma (SEGA) in patients with tuberous sclerosis complex (TSC)
 
Label Changes Summary:  Approved for patients 1 year and older with TSC for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected The safety and effectiveness of Afinitor Tablets and Afinitor Disperz have not been established in pediatric patients with renal angiomyolipoma with TSC in the absence of SEGA The effectiveness in pediatric patients with SEGA was demonstrated in two clinical trial The long term effects of Afinitor on growth and pubertal development are unknown Information on starting dose, therapeutic drug monitoring, clinical trial, and adverse reactions New formulation
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Novalar Pharmaceuticals, Inc.
 
Pediatric Exclusivity Granted Date:  07/10/2012
 
NNPS:  FALSE'
 
Therapeutic Category:  Antineoplastic
 
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