• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
-
 
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
 
-
-