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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:  09/20/2007
 
Trade Name:  Norditropin Cartridges
 
Generic Name or Proper Name (*):  somatropin (rDNA origin)
 
Indications Studied:  Treatment of short stature in children with Turner syndrome
 
Label Changes Summary:  * Safety and effectiveness based on studies in pediatric patients * New Warning: Patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear and hearing disorders. Somatropin treatment may increase the occurrence of otitis media in patients with Turner syndrome. In addition, patients with Turner syndrome should be monitored closely for cardiovascular disorders (e.g., stroke, aortic aneurysm/dissection, hypertension) as these patients are also at risk for these conditions * Information on recommended dosing, adverse events (AEs) and clinical studies * New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Novo Nordisk
 
NNPS:  FALSE
 
Therapeutic Category:  Growth hormone
 
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