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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:  11/01/2006
 
Trade Name:  Humatrope for injection
 
Generic Name or Proper Name (*):  somatropin (rDNA origin)
 
Indications Studied:  Treatment of short stature or growth failure in children with short stature homeobox-containing gene (SHOX) deficiency
 
Label Changes Summary:  * Effectiveness established from one 2-year study for SHOX in 52 pediatric patients * Information on adverse events provided * Dosing information provided * New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Lilly
 
NNPS:  FALSE
 
Therapeutic Category:  Growth hormone
 
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