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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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