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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:  04/27/2006
 
Trade Name:  Genotropin Injection
 
Generic Name or Proper Name (*):  somatropin (rDNA origin)
 
Indications Studied:  Long-term treatment of growth failure associated with Turner syndrome
 
Label Changes Summary:  Indicated for use in pediatric patients with open epiphyses Effectiveness and safety based on studies in pediatric patients New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Pharmacia & Upjohn
 
NNPS:  FALSE'
 
Therapeutic Category:  Growth hormone
 
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