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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
Sponsor:  Pharmacia & Upjohn
Therapeutic Category:  Growth hormone